Even in Intensive Care, Health Care Costs Are Factor For Both Patients and Clinicians

MedicalResearch.com Interview with:

Deborah D. Gordon, MBA Mossavar-Rahmani Center for Business and Government Harvard Kennedy School Cambridge, Massachusetts

Deborah  Gordon

Deborah D. Gordon, MBA
Mossavar-Rahmani Center for Business and Government
Harvard Kennedy School
Cambridge, Massachusetts

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Against the backdrop of rising health care costs, and the increasing share of those costs that consumers bear, studies show people are interested in finding health care cost information and engaging with their providers on issues of cost.

We were interested in learning to what extent, if any, discussion or consideration of cost would be documented in electronic health records.

Using machine learning techniques to extract data from unstructured notes, we examined 46,146 narrative clinical notes from ICU admissions. We found that approximately 4% of admissions had at least one note with financially relevant content. That financial content included documentation of cost as a barrier to adhering to treatment prior to admission, and as a consideration in treatment and discharge planning.    Continue reading

Critical Illness: Haloperidol and Ziprasidone for Treatment of Delirium

MedicalResearch.com Interview with:

Brenda Truman Pun, DNP, RN Program Clinical Manager Vanderbilt University Medical Center

Dr. Truman Pun

Brenda Truman Pun, DNP, RN
Program Clinical Manager
Vanderbilt University Medical Center

MedicalResearch.com: What is the background for this study?

Response: Delirium is a serious problem in Intensive Care Units around the world. Approximately 80% of mechanically ventilated patients develop delirium, acute confusion, while in the ICU. Once thought to be a benign side effect of the ICU environment, research now shows that delirium is linked to a myriad of negative outcomes for patients which include longer ICU and Hospital stays, prolonged time on the ventilator, increased cost, long-term cognitive impairment and even mortality. For a half a century clinicians have been using haloperidol, an typical antipsychotic, to treat delirium in the ICU. However, there has never been evidence to support the use of haloperidol or its pharmacologic cousins, the atypical antipsychotics, to treat delirium. These drugs have serious side effects that include heart arrhythmias, muscle spasms, restlessness and are associated with increased mortality when given for prolonged periods in the outpatient settings leading to a black box warning for their use in this setting.

The MIND-USA study was a double blind placebo controlled trial which evaluated the efficacy and safety of antipsychotics (i.e., haloperidol and ziprasidone) in the treatment delirium in adult ICU patients.   Continue reading

No Benefit, More Complications with Hypothermia after Traumatic Brain Injury

MedicalResearch.com Interview with:

Jamie Cooper AO BMBS MD FRACP FCICM FAHMS Professor of Intensive Care Medicine Monash University Deputy Director & Head of Research,  Intensive Care & Hyperbaric Medicine The Alfred, Melbourne

Prof. Cooper

Jamie Cooper AO
BMBS MD FRACP FCICM FAHMS
Professor of Intensive Care Medicine
Monash University
Deputy Director & Head of Research,
Intensive Care & Hyperbaric Medicine
The Alfred, Melbourne

MedicalResearch.com: What is the background for this study?

Response: 50-60 million people each year suffer a traumatic brain injury (TBI) . When the injury is severe only one half are able to live independently afterwards.

Cooling the brain (hypothermia) is often used in intensive care units for decades to  decrease inflammation and brain swelling and hopefully to improve outcomes, but clinical staff have had uncertainty whether benefits outweigh complications.

We conducted the largest randomised trial of hypothermia in TBI, in 500 patients, in 6 countries, called POLAR. We started cooling by ambulance staff, to give hypothermia the best chance to benefit patients. We continued for 3-7 days in hospital ind ICU. We measured functional outcomes at 6 months.

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Do Antipsychotics Shorten Duration of Delirium in ICU Patients?

MedicalResearch.com Interview with:

Eugene Wesley Ely, M.D. Dr. E. Wesley Ely is a Professor of medicine at Vanderbilt University School of Medicine with subspecialty training in Pulmonary and Critical Care Medicine.

Dr. Ely
Photo: Anne Rayner, VU

Eugene Wesley Ely, M.D.
Dr. E. Wesley Ely is a Professor of medicine at Vanderbilt University School of Medicine with subspecialty training in Pulmonary and Critical Care Medicine. 

MedicalResearch.com: What is the background for this study?

Response: Critically ill patients are not benefitting from antipsychotic medications that have been used to treat delirium in intensive care units (ICUs) for more than four decades, according to a study released today in the New England Journal of Medicine.

Each year, more than 7 million hospitalized patients in the United States experience delirium, making them disoriented, withdrawn, drowsy or difficult to wake.

The large, multi-site MIND USA (Modifying the INcidence of Delirium) study sought to answer whether typical and atypical antipsychotics — haloperidol or ziprasidone —affected delirium, survival, length of stay or safety.

Researchers screened nearly 21,000 patients at 16 U.S. medical centers. Of the 1,183 patients on mechanical ventilation or in shock, 566 became delirious and were randomized into groups receiving either intravenous haloperidol, ziprasidone or placebo (saline).

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Who is Really Sick? Eyeball Assessment vs Formal Triage

MedicalResearch.com Interview with:

Dr Anne Kristine Servais Iversen, Anne Kristine Servais Iversen Department of Obstetrics and Gynecology Rigshospitalet Copenhagen, Denmark 

Dr. Servais Iversen

Dr Anne Kristine Servais Iversen,
Anne Kristine Servais Iversen
Department of Obstetrics and Gynecology
Rigshospitalet
Copenhagen, Denmark 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Systematic triage has been implemented worldwide with different triage scales in use all over the world. Prior to the introduction of formalised triage, patients were prioritised based on clinical assumption.

After the introduction of formalised triage only a few studies have assessed agreement between formal and informal triage. Additionally, the majority of formalised triage scales are supported by limited and often insufficient evidence. This is troublesome since formalised triage forces clinicians to follow an algorithm rather than use their experience and clinical judgement. During my own residency at a Danish Emergency ward I was often contacted by the nurse performing formalised triage telling me that a patient she was assessing scored to be very acute (high triage level), but that she didn’t believe that to be the case. In order for her to prioritise the patient to a lower (less acute) triage level the patient had to be assessed by a doctor.

Very often my colleagues and I would agree with the nurse in that the scoring was to high, and we therefore had to overrule the formalised triage decision. In cases like these you ask yourself whether or not we are using the most effective and best form of triage for initial patient sorting.

Our study found that agreement between formalised triage and a quick clinical assessment in the form of Eyeball triage is poor. It also suggest that eyeball triage better predicts those at highest risk of death within 48-hours and 30 days after assessment.

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Critical Illness Linked To Brain Changes Associated with Cognitive Decline

MedicalResearch.com Interview with:

Keenan Walker, PhD Johns Hopkins University School of Medicine  Baltimore

Dr. Walker

Keenan Walker, PhD
Johns Hopkins University School of Medicine
Baltimore

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study was conducted in response to anecdotal accounts and scientific evidence which suggests that major medical conditions, such as critical illness and severe infections, can have a long-term neurological effect on some individuals.

There are quite a few studies to date which have found that critical illnesses, such as severe sepsis, are associated with long-term cognitive impairment. Based on this evidence, we wanted to figure out to what degree critical illness and major infection may affect later brain structure and to determine whether the structural changes associated with these events were similar to those observed in Alzheimer’s disease.

Our main finding was that individuals who had one or more critical illness or major infection major infection during the decades leading up to older adulthood were more likely to have smaller brain volumes in brain regions most vulnerable to Alzheimer’s disease.

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Real World Treatment of Serious Infections with Ceftolozane/Tazobactam

MedicalResearch.com Interview with:

Thomas P. Lodise Jr., PharmD, PhD Clinical Pharmacist at the Stratton VA Medical Center in Albany, NY Albany College of Pharmacy and Health Sciences Albany, NY

Dr. Lodise

Thomas P. Lodise Jr., PharmD, PhD
Clinical Pharmacist at the Stratton
VA Medical Center in Albany, NY
Albany College of Pharmacy and Health Sciences
Albany, NY

MedicalResearch.com: What is the background for this study? How does Ceftolozane/Tazobactam differ from other antibiotics for serious Gram-negative infections including Pseudomonas aeruginosa?

Response: Treatment of patients with Gram-negative infections is increasingly difficult due to rising resistance to commonly used agents. Ceftolozane/tazobactam (C/T) is a potent anti-pseudomonal agent with broad Gram-negative coverage that is indicated for complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) and is currently being studied for ventilated nosocomial pneumonia. C/T differs from other antibiotics in terms of its potency against multi-drug resistant Pseudomonas aeruginosa, one of the most concerning and difficult-to-treat Gram-negative pathogens. This study evaluates C/T in a large database of US hospitals to better understand treatment patterns and associated outcomes.

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Bezlotoxumab (Zinplava)For Prevention of Recurrent C. Difficile Infection

MedicalResearch.com Interview with:
Richard Hengel, MD, FRCPC, FACP Atlanta ID Group
Richard Hengel, MD, FRCPC, FACP

Atlanta ID Group

MedicalResearch.com: What is the background for this study? How does Bezlotoxumab differ from other medications for recurrent C. difficile infections?

Response: Clostridium difficile infection (CDI) is now the most common hospital acquired infection in the United States, accounting for significant morbidity and mortality, not only in the US, but around the world. Despite standard antibiotic therapy targeting the Clostridium difficile bacterium directly, recurrent infection is common, occurring in a quarter to a third of patients, often frail individuals with other concurrent medical problems. These patients can have multiple recurrences leading to their progressive deterioration over time. Until recently, the only treatment for CDI included antibiotics. More recently, fecal microbiota transplant is a promising, but as yet, FDA unapproved therapy. Bezlotoximab is a new FDA approved treatment for recurrent Clostridium difficile infection (rCDI) that compliments standard antibiotics. Bezlotoxumab is a monoclonal antibody targeting toxin B produced by Clostridium difficile during CDI. In two large treatment trials, bezotoxumab, in addition to standard-of-care antibiotics, reduced the frequency of CDI recurrences from about 28% to about 18%. In this study, we set out to see if this new drug performed as well in actual clinical practice as it did in the published clinical trials.

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New Antibiotic Combination IMI/REL Can Treat Resistant Infection With Less Kidney Toxicity

MedicalResearch.com Interview with:

Michelle Hoffman Brown Associate Principal Scientist at Merck Merck

Michelle Brown

Michelle Hoffman Brown
Associate Principal Scientist
Merck

MedicalResearch.com: What is the background for this study? What are the kidney risks of using colistin to treat carbapenem-resistant bacterial infections?

Response: Gram-negative pathogens are responsible for half of all healthcare-associated infections and their ability to resist traditional antibiotics makes them more dangerous for seriously ill patients in a healthcare setting. The need for new approaches to treat these pathogens is essential and this trial aimed to evaluate the efficacy and safety of imipenem/relebactam (IMI/REL) for the treatment of these challenging infections.

Nephrotoxicity is a common complication of colistin-based therapy and is the potential adverse experience of greatest concern to prescribing clinicians, limiting its use to treat carbapenem-resistant bacterial infections. Relebactam is a novel β-lactamase inhibitor that restores imipenem activity against many imipenem-non-susceptible strains of Gram-negative pathogens. In the Phase 3 RESTORE-IMI 1 study (NCT02452047), IMI/REL was shown to be as effective as, but better tolerated than, colistin plus imipenem, including as demonstrated by a lower incidence of treatment-emergent nephrotoxicity (prespecified secondary endpoint). This analysis looked at additional renal safety data from the RESTORE-IMI 1 trial.  Continue reading

NEJM: Rivaroxaban (XARELTO®) For Thromboembolism Prevention after Medical Illness

MedicalResearch.com Interview with:

Alex C Spyropoulos, MD, FACP, FCCP, FRCPC Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Professor - The Center for Health Innovations and Outcomes Research - The Feinstein Institute for Medical Research System Director – Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital New York, NY 10075

Dr. Spyropoulos

Alex C Spyropoulos, MD, FACP, FCCP, FRCPC
Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Professor – The Center for Health Innovations and Outcomes Research – The Feinstein Institute for Medical Research
System Director – Anticoagulation and Clinical Thrombosis Services
Northwell Health at Lenox Hill Hospital
New York, NY 10075

MedicalResearch.com: What is the background for this study?

Response: Hospitalised medically ill patients have a significant risk of developing venous thromboembolism (VTE) within 6 weeks after discharge. The role of extended thromboprophylaxis in this population with either low molecular weight heparin or the direct oral anticoagulants remains uncertain, as it has shown either excess bleeding or beneficial effects mainly from reducing asymptomatic deep vein thrombosis (DVT).

The MARINER trial was designed to compare rivaroxaban with placebo for the prevention of the composite outcome of symptomatic VTE and VTE-related death in medically ill patients at increased risk of VTE post-hospital discharge. The principal safety objective was major bleeding.

The trial was a randomized, double-blind, placebo-controlled, event-driven study that included a total of 12,024 patients aged ≥40 years who had been hospitalised with an acute medical illness for 3-10 consecutive days and had additional VTE risk factors as defined by the modified IMPROVE VTE risk score of ≥4 or a score of 2 or 3 plus a plasma D-dimer level more than twice the upper limit of normal). The rivaroxaban regimen consisted of 10 mg once daily in patients with a creatinine clearance (CrCl) of >=50ml/min or 7.5 mg for patients with a CrCl of 30 to <50 ml/min. The first dose was given on the day of discharge and the last dose at Day 45. Patients were followed up for an additional 30 days. Baseline characteristics were well matched between groups and typical of a medically ill population.

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When Should Children in Pediatric Intensive Care Receive Parenteral Nutrition?

MedicalResearch.com Interview with:

Sascha Verbruggen, MD, PhD Pediatric intensivist Erasmus MC-Sophia Children's Hospital

Dr. Verbruggen

Sascha Verbruggen, MD, PhD
Pediatric intensivist
Erasmus MC-Sophia Children’s Hospital

MedicalResearch.com: What is the background for this study?

Response: In critically ill children treated in the pediatric intensive care unit (PICU) are often difficult to feed. The subsequent macronutrient deficit was found to be associated with impaired outcomes in the PICU. Furthermore, being undernourished in the PICU has also been associated with poor outcome of critical illness in children.

These associations formed the basis for guidelines recommending initiation of parenteral nutritional support early when enteral feeding is insufficient. However, the multicenter randomised controlled trial (RCT) ‘Pediatric Early versus Late Parenteral Nutrition in Critical Illness’ (PEPaNIC), including 1440 critically ill children, showed that withholding PN for one week (Late-PN) resulted in fewer new infections and reduced the duration of PICU stay as compared to initiating PN at day 1 (Early-PN). However, withholding PN for one week in critically ill children, who are already undernourished upon admission to the PICU, raised concerns among experts.

Therefore we set out to investigate the impact of withholding supplemental PN in a subgroup of critically ill children who were acutely undernourished upon admission to the PICU.  Continue reading

First Trial Compares Treatment Options For Serious Infections Caused by ESBL-Producers

MedicalResearch.com Interview with:

Patrick Harris FRACP Staff Specialist Microbiology | Pathology Queensland | Health Support Queensland Postdoctoral Research Fellow University of Queensland, UQ Centre for Clinical Research (Paterson Group)

Dr. Harris

Patrick Harris FRACP
Staff Specialist
Microbiology | Pathology Queensland | Health Support Queensland
Postdoctoral Research Fellow
University of Queensland, UQ Centre for Clinical Research (Paterson Group

MedicalResearch.com: What is the background for this study?

Response: Increasingly, common bacterial pathogens such as E. coli or Klebsiella have acquired genes known as extended-spectrum beta-lactamases (ESBLs), which mediate resistance to many of our most important antibiotics. Despite their clinical importance, we have limited information derived from randomised clinical trials on the best antibiotic treatments for life-threatening infections caused by these ESBL-producers.

We aimed to compare two readily available antibiotics, meropenem (a carbapenem drug, as the “standard of care”) and piperacillin-tazobactam (which may be an alternative to meropenem). Many ESBL-producing bacteria test susceptible to piperacillin-tazobactam in the laboratory, yet clinical efficacy has been uncertain.  Some observational studies have suggested that piperacillin-tazobactam may be effective against ESBL-producers, but the data have been contradictory.  The theory has been that piperacillin-tazobactam may be less likely to select for resistance to carbapenems – which, when it occurs, can result in infection with bacteria that are almost untreatable.

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Active Shooter Incidents Involving Semi-automatic Rifles More Deadly

MedicalResearch.com Interview with:

Adil Haider, MD, MPH, FACS Kessler Director for the Center for Surgery and Public Health Brigham and Women’s Hospital, Harvard Medical School, and Harvard T.H. Chan School of Public Health Deputy Editor of JAMA Surgery

Dr. Haider

Adil Haider, MD, MPH, FACS
Kessler Director for the Center for Surgery and Public Health
Brigham and Women’s Hospital, Harvard Medical School, and
Harvard T.H. Chan School of Public Health
Deputy Editor of JAMA Surgery

MedicalResearch.com: What is the background for this study?

Response: Firearm-related mortality is a public health issue. However, in the US, due in part to lack of funding, there is not enough research to inform the debate about firearms.

The question our group sought to answer was to understand if the presence of a semi-automatic weapon increased the number of victims killed or hurt during an active shooter incident. We chose to focus on these incidents given the availability of an FBI database detailing these active shooter incidents based on a strict definition and the similarities between such incidents that make a comparison valid.

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Does Routine Oxygen After Heart Attack Reduce Risk of Dying?

MedicalResearch.com Interview with:

Robin Hofmann, MD PhD  Senior consultant cardiologist and researcher Department of clinical science and education Södersjukhuset, at Karolinska Institute

Dr. Hofmann

Robin Hofmann, MD PhD
Senior consultant cardiologist and researcher
Department of clinical science and education
Södersjukhuset, at Karolinska Institute

MedicalResearch.com: What is the background for this study?

Response: Oxygen has been used to treat patients suffering a heart attack for more than a century, despite the fact that such treatment has not had any scientifically proven effect on patients who have normal oxygen levels in their blood. Since the turn of the millennium, researchers worldwide have started to question whether oxygen therapy for heart attacks is ineffective – or may even be harmful.

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Daily Chest X-Rays Still Overused in Mechanically Ventilated Patients

MedicalResearch.com Interview with:

Hayley B. Gershengorn, MD Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, Miami, Florida Division of Critical Care Medicine, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York

Dr. Gershengorn

Hayley B. Gershengorn, MD
Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, Miami, Florida
Division of Critical Care Medicine, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Beginning in December, 2011, professional guidelines have recommended against the practice of daily chest radiography (CXRs) for mechanically ventilated patients.  However, we hypothesized that this practice was still commonplace in the US and varied from hospital to hospital.

To address this question, we performed a retrospective cohort study of >500,000 mechanically ventilated adults across 416 US hospitals. We found that 63% of these patients received daily CXRs and that, while use has been decreasing, this decrease is small (a 3% relative reduction in the odds of daily CXR receipt per discharge quarter starting in 2012).

Moreover, the hospital at which a patient received care greatly impacted the likelihood of daily CXR receipt.

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Leg cycling and electrical muscle stimulation for the critically ill? Still many peaks to climb up

MedicalResearch.com Interview with:
“cycling” by Urs Steiner is licensed under CC BY 2.0Guillaume Fossat, Physiotherapist and
Thierry Boulain, M.D.
Médecine Intensive Réanimation
Centre Hospitalier Régional
Orléans, France

MedicalResearch.com: What is the background for this study?

Response: Critically ill patients may suffer terrific muscle wasting during their intensive care unit stay. In most patients, particularly those with sepsis or other high inflammatory states, this is due to proteolytic pathways runaway that may persist as long as the cause of inflammation has not been eliminated. What is more, forced rest, as the one imposed to severely ill patients who need sedation to tolerate artificial respiratory support also induces muscle deconditioning and mass loss. In short, the more you are severely and acutely ill, the more you breakdown your muscle proteins and use the catabolic byproducts to fuel the rest of your organism. As a result of this sort of autophagy, intensive care unit survivors may have lost tens of muscle mass kilograms at discharge, to the point that they have lost all or parts of their functional autonomy. The personal and social burden is considerable as muscle weakness may persist several years after hospital discharge.

In the 2000’s, physiotherapy and early rehabilitation during intensive care have emerged as a way to counteract the autophagic muscle wasting and help patients to speed up their return to functional autonomy. Therefore, a standardized early rehabilitation that consists in early muscle exercises, systematic lowering or interruption of sedative drugs dosages to allow prompt patient’s awaking, early transfer to chair and early first walk try, has become the standard of care. However, to what extent, when and how muscles should be exercised during the intensive care unit stay in order to optimize the positive effects of rehabilitation remains a nearly blank clinical research area.

In-bed leg cycling and electrical muscle stimulation, each for their part, have shown encouraging results. In our study, we sought to know if the very early combination of both could improve global muscle strength in survivors at intensive care unit discharge.

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“Rory’s Regulations” Improves Pediatric Sepsis Care

MedicalResearch.com Interview with:

Idris V.R. Evans, M.D.,MA Assistant Professor Department of Critical Care Medicine University of Pittsburgh

Dr. Evans

Idris V.R. Evans, M.D.,MA
Assistant Professor
Department of Critical Care Medicine
University of Pittsburgh

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: New York State issued a state-wide mandate in 2013 for all hospitals to develop protocols for sepsis recognition and treatment. This mandate was called “Rory’s Regulations” in honor of Rory Staunton, a boy who died from sepsis in 2012.

Pediatric protocols involved a bundle of care that included blood cultures, antibiotics, and an intravenous fluid bolus within 1–hour. We analyzed data collected by the NYS Department of Health on 1,179 patients from 54 hospitals and found that the completion of the pediatric bundle within 1 hour was associated with a 40% decrease in the odds of mortality.  Continue reading

How Doctors Communicate Empathy Critical to Family-Physician Partnership

MedicalResearch.com Interview with:

Dr. Tessie W. October. MD, MPH Critical Care Specialist Children’s National Health System

Dr. October

Dr. Tessie W. October. MD, MPH
Critical Care Specialist
Children’s National Health System 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: This is a qualitative study that examines the impact of empathetic statements made by doctors on the ensuing conversation with families of critically ill children. We know families are more satisfied when doctors show empathy, but until this study, we did not know how these empathetic statements are received by families. In this study we found that doctors frequently respond to a family’s emotions by responding with empathy, but how the doctor presented that empathetic statement mattered. When doctors made an empathetic statement, then paused to allow time for a family’s response, the family was 18 times more likely to share additional information about their fears, hopes or values. Conversely, when doctors buried the empathetic statement within medical talk or if a second doctor interrupted, the empathetic statement frequently went unheard by the family.

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Family-Support Intervention in ICUs Increased Patient Comfort and Reduced Costs

MedicalResearch.com Interview with:

Douglas B. White, M.D., M.A.S. Director of the Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center’s Program on  Ethics and Decision Making in  Department of Critical Care Medicine University of Pittsburgh 

Dr. White

Douglas B. White, M.D., M.A.S.
Director of the Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center’s Program on
Ethics and Decision Making in  Department of Critical Care Medicine
University of Pittsburgh 

MedicalResearch.com: What is the background for this study? 

Response: We set out to test the effectiveness of PARTNER (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building). PARTNER is delivered by the interprofessional team in the ICU, consisting of nurses, physicians, spiritual care providers, social workers and others who play a part in patient care. The program is overseen by nurse-leaders in each ICU who receive 12 hours of advanced communication skills training to support families. The nurses meet with the families daily and arrange interdisciplinary clinician-family meetings within 48 hours of a patient coming to the ICU. A quality improvement specialist helps to incorporate the family support intervention into the clinicians’ workflow.

PARTNER was rolled out at five UPMC ICUs with different patient populations and staffing. It was implemented in a staggered fashion so that every participating ICU would eventually get PARTNER. Before receiving PARTNER, the ICUs continued their usual methods of supporting families of hospitalized patients. None of the ICUs had a set approach to family communication or required family meetings at regular intervals before receiving PARTNER. A total of 1,420 adult patients were enrolled in the trial, and 1,106 of these patients’ family members agreed to be a part of the study and its six-month follow-up surveys. The patients were very sick, with about 60 percent dying within six months of hospitalization and less than 1 percent living independently at home at that point.

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Reducing Opioids Near End of Hospital Stay May Limit Outpatient Use

MedicalResearch.com Interview with:

Jason Kennedy, MS Research project manager Department of Critical Care Medicine University of Pittsburgh

Jason Kennedy

Jason Kennedy, MS
Research project manager
Department of Critical Care Medicine
University of Pittsburgh

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Most previous studies of opioid use in health care have focused on the outpatient setting. But opioids are often introduced during hospitalization. That’s something clinicians can control, so we looked at inpatient prescription of these drugs to identify targets that may reduce opioid use once patients are out of the hospital.

We analyzed the medical records of 357,413 non-obstetrical adults hospitalized between 2010 and 2014 at 12 University of Pittsburgh Medical Center (UPMC) hospitals in southwestern Pennsylvania. The region is one of the areas of the country where opioid addiction is a major public health problem. We focused on the 192,240 patients who had not received an opioid in the year prior to their hospitalization – otherwise known as “opioid naïve” patients.

Nearly half (48 percent) of these patients received an opioid while hospitalized.  After discharge, those patients receiving hospital opioids were more than twice as likely to report outpatient opioid use within 90-days (8.4 percent vs. 4.1 percent). Patients who receive an opioid for most of their hospital stay and patients who are still taking an opioid within 12 hours of being discharged from the hospital appear more likely to fill a prescription for opioids within 90 days of leaving the hospital.  Continue reading

NICU Babies’ Parents at Risk For Depression

MedicalResearch.com Interview with:

Karen Fratantoni, M.D., M.P.H. Pediatrician and lead study author Children’s National Health System

Dr. Fratantoni

Karen Fratantoni, M.D., M.P.H.
Pediatrician and lead study author
Children’s National Health System

MedicalResearch.com: What is the background for this study?

Response: We looked at the prevalence of depressive symptoms at NICU discharge and at six months after discharge among 125 parents randomized to the control group of a larger PCORI-funded trial of peer-to-peer support after NICU discharge. Determining factors associated with parental depressive symptoms at NICU discharge may help to identify at-risk parents who could benefit from mental health support.

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Pneumonia Patients on Ventilators May Benefit from New Ceftolozane/Tazobactam Antibiotics

MedicalResearch.com Interview with:

Dr. Elizabeth Rhee MD Director, Infectious Disease Clinical Research at Merck

Dr. Rhee

Dr. Elizabeth Rhee MD
Director, Infectious Disease Clinical Research Merck

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: High-risk patients, such as the critically ill, with suspected bacterial infections require prompt treatment with appropriate empiric therapy to improve survival. Given the high prevalence of multidrug-resistant (MDR) Pseudomonas aeruginosa in the ICU setting, new safe and broadly effective treatment options are needed for critically ill patients requiring antipseudomonal agents.

Ceftolozane/tazobactam (C/T) is an antipseudomonal cephalosporin/beta-lactamase inhibitor combination with broad in vitro activity against Gram-negative pathogens, including MDR P. aeruginosa and many extended-spectrum beta-lactamase (ESBL) producers. It is FDA approved for complicated intra-abdominal and urinary tract infections in adults at 1.5g (1g/0.5g) q8h. C/T is currently being studied at 3g (2g/1g) q8h, for the treatment of ventilated nosocomial pneumonia, in the ASPECT-NP Phase 3 trial.

This Phase 1 pharmacokinetic (PK) study investigated the penetration of a 3g dose of C/T in the epithelial lining fluid (ELF) of ventilated patients with proven or suspected pneumonia. This is the dose and patient population being evaluated in ASPECT-NP. ELF lines the alveoli, and investigators took samples in a group of 26 patients to see what amount of C/T was in the lung and what was circulating in the plasma during the dosing intervals.

In mechanically ventilated critically ill patients, the 3g dose of C/T achieved ≥50% lung penetration (relative to free plasma) and sustained levels in ELF above the target concentrations for the entire dosing interval. These findings support the 3g dose that is included in the ASPECT-NP Phase 3 trial.  Continue reading

New Cephalosporin Combination Tested for Complicated Sepsis Patients

MedicalResearch.com Interview with:

Becky Jayakumar, PharmD College of Pharmacy Assistant Professor of Pharmacy Practice Roseman University of Health Sciences

Dr. Jayakumar

Becky Jayakumar, PharmD
College of Pharmacy
Assistant Professor of Pharmacy Practice
Roseman University of Health Sciences

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Bacteremia (bloodstream infections) due to Gram-negative (GN) bacteria are a frequent cause of severe sepsis and pose serious therapeutic challenges due to multidrug-resistance (MDR). Ceftolozane/tazobactam (C/T) is a novel antipseudomonal cephalosporin combined with an established β-lactamase inhibitor.

This retrospective, observational study evaluated the clinical outcomes of C/T real-world use in severely ill patients. Twenty-two patients with sepsis and/or bacteremia were included; 95% of whom had Pseudomonas aeruginosa that was resistant to almost all antibacterials with the exception of colistin. C/T successfully treated the majority of these complicated patients. In this real-world study, 77% of patients had a clinical response with C/T and 75% had a microbiological response. Clinical success rates were high and mortality rates were similar to other studies in this severely ill population. Continue reading

Merck Tests New Antibiotic Combination For Hard to Treat Bacterial Infections

MedicalResearch.com Interview with:

Amanda Paschke, MD, MSCE Senior principal scientist Infectious disease clinical research Merck Research Laboratories

Dr.Amanda  Paschke

Amanda Paschke, MD, MSCE
Senior principal scientist
Infectious disease clinical research
Merck Research Laboratories

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study sought to evaluate a new beta-lactam/beta-lactamase inhibitor antibacterial combination, imipenem/relebactam (IMI/REL), compared with colistin plus imipenem for the treatment of infections caused by resistant Gram-negative bacteria.

Patients enrolled in the trial had hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), complicated intra-abdominal infections (cIAI), or complicated urinary tract infections (cUTI) caused by pathogens that were non susceptible to imipenem, a carbapenem antibacterial.

In this study, the primary outcome was a favorable overall response to treatment, which was comparable between the IMI/REL vs colistin + IMI arms. Colistin (often combined with a carbapenem) is currently among the standard of care treatment regimens for MDR infections.  A key secondary endpoint of the study was safety.  IMI/REL was well tolerated; among all treated patients, drug-related adverse events (AEs) occurred in 16.1% of IMI/REL and 31.3% of colistin + IMI patients with treatment-emergent nephrotoxicity observed in 10% (3/29 patients) and 56% (9/16 patients), respectively (p=0.002). Results of the trial support the use of imipenem-relebactam (IMI/REL) as an efficacious and well-tolerated treatment option for carbapenem-resistant infections.  Continue reading

One Blood Type Is a Risk For Bleeding Out After Trauma

MedicalResearch.com Interview with:
Dr. Wataru Takayama
Tokyo Medical and Dental University
Department of Emergency and Disaster Medicine
Tokyo, Japan

MedicalResearch.com: What is the background for this study?

Response: ABO blood type is a potential risk of various diseases and various conditions. Furthermore, ABO blood type has a profound influence on hemostasis. Hemorrhage is the leading cause of death in patients with trauma, we assessed the association between the difference in blood types and the outcomes of death.

MedicalResearch.com: What are the main findings?

Response: Blood type O was the independent risk factor for all-cause in-hospital mortality and death due to exsanguination, TBI, and other causes after adjusting for potential confounders. This is the first study to report the association between ABO blood types and mortality in patients with severe trauma.

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