30 Nov Fenoldopam Does Not Prevent Acute Kidney Injury After Cardiac Surgery
Medical Research: What is the background for this study?
Dr. Landoni: The prevention and treatment of acute kidney injury after cardiac surgery is a major therapeutic goal, but no effective agents have yet been identified. Meta-analyses suggested that fenoldopam might be effective.
Medical Research: What are the main findings?
Dr. Landoni: We found that in cardiac surgery patients with early acute kidney injury (defined as a ≥50% increase of serum creatinine from baseline or oliguria for ≥6 hours), fenoldopam had no impact on the need for renal replacement therapy or 30-day mortality, while increasing the rate of hypotension.
Medical Research: What should clinicians and patients take away from your report?
Dr. Landoni: Fenoldopam is available in Europe and the USA. It was approved by FDA in 1997 and indicated for the in-hospital, short-term management of severe hypertension. Fenoldopam has not gained FDA approval for renal indications although it has been widely used off label in the USA for kidney protection in various settings. Our trial demonstrates that fenoldopam is not effective for the prevention and treatment of AKI in cardiac surgery and, by analogy, suggests that effectiveness might also be absent in other patients with early AKI.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Landoni: The study provides evidence against fenoldopam use as an off-label kidney protection strategy in cardiac surgery, but other settings and other populations of patients with early AKI should be investigated to strengthen this statement. Furthermore, there is a need for a paradigm change in kidney protection after surgery and this study contributes to highlight the need for new strategies and molecules in this field.
Effect of Fenoldopam on Use of Renal Replacement Therapy Among Patients With Acute Kidney Injury After Cardiac Surgery: A Randomized Clinical Trial
Bove T1, Zangrillo A2, Guarracino F3, Alvaro G4, Persi B5, Maglioni E6, Galdieri N7, Comis M8, Caramelli F9, Pasero DC10, Pala G11, Renzini M12, Conte M13, Paternoster G14, Martinez B15, Pinelli F16, Frontini M17, Zucchetti MC18, Pappalardo F1, Amantea B4, Camata A5, Pisano A7, Verdecchia C8, Dal Checco E9, Cariello C3, Faita L4, Baldassarri R3, Scandroglio AM1, Saleh O1, Lembo R1, Calabrò MG1, Bellomo R19, Landoni G2.
JAMA. 2014 Sep 29. doi: 10.1001/jama.2014.13573. [Epub ahead of print]