drugset / Trial / NCT01758861

Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery

NCT01758861 ↗

Phase 2 Completed 98 enrolled Yonsei University
RandomizedParallel-groupTriple-blindPrevention

Summary

Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the present study was to investigate the effect of a single preoperative bolus of EPO on the incidence of AKI following complex valvular heart surgery in a randomized, controlled and double-blind trial.

Timeline

Start
2011-07
Primary completion
2012-09
Completion
2012-10

Outcome

Missed primary endpoint

paper Incidence of postoperative AKI (32.7% versus 34.7%, P = 0.831) PMID 24156702 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject recombinant human erythropoietin Protein / enzyme biologic 300 iu/kg Intravenous

Indications