Regionale Citrat- versus systemische Heparin-Antikoagulation für das kontinuierliche Nierenersatzverfahren bei kritisch kranken Patienten mit akuter Nierenschädigung (RICH-Trial)

Grunddaten zu diesem Projekt

Beschreibung

Acute kidney injury (AKI) is a well-recognized complication of critical illness with an important impact on morbidity, mortality, and health resource utilization. Renal replacement therapy (RRT) causes a considerable escalation in the complexity of treatment, has inherent risks for adverse effects and increases cost of care for those with severe AKI. To this date it is not clear whether regional citrate anticoagulation or systemic heparin anticoagulation for CRRT should be used. We hypothesize that regional citrate anticoagulation for CRRT prolongs filter life and decreases the 90-day all cause mortality compared to the use of systemic heparin anticoagulation. We will conduct a prospective, randomized, multicenter, controlled trial including 1450 critically ill patients with AKI requiring CRRT. We propose to investigate the effect of regional citrate anticoagulation for CRRT compared to systemic heparin anticoagulation for CRRT. The primary outcome parameters are the filter life and the overall survival in a 90-day follow-up period (90-day all cause mortality). Secondary endpoints are the length of stay on the intensive care unit, length of hospitalization, duration of renal replacement therapy, recovery of renal function, requirement for hemodialysis after day 28 and day 60, 28-day all cause mortality, 60-day all cause mortality, 1-year mortality, bleeding complications, transfusion requirements, rate of infection, and cost analysis of renal replacement therapy. Additionally in an add-on study involving several centers, blood samples from recruited patients will collected and analyzed. As the currently available data on the topic is inconclusive, this prospective, randomized, multicenter trial is needed to provide evidence for the best anticoagulation regimen for CRRT in critically ill patients with AKI.