drugset / Trial / NCT00286273

Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration

NCT00286273

Phase 4 Completed 215 enrolled Onze Lieve Vrouwe Gasthuis
RandomizedParallel-groupOpen-labelTreatment

Summary

Severely ill patients admitted to the intensive care unit may develop an acute failure of kidney function. To bridge the period to recovery, renal function is temporarily replaced by continuous venovenous hemofiltration (CVVH). To prevent clotting of the hemofiltration circuit, heparin is generally used, providing anticoagulation in the circuit and the patient. As a result, bleeding complications may occur, necessitating the transfusion of blood. Anticoagulation of the circuit can also be obtained with the use of tri-sodium citrate, which provides anticoagulation of the circuit without affecting coagulation in the patient and thus without increasing his/her risk of bleeding. The use of citrate may however cause metabolic complications. Primary aim of the present study is to show in a larger group of intensive care patients whether the use of regional anticoagulation with citrate is safe compared to systemic anticoagulation with the low molecular weight heparin nadroparin.

Timeline

Start
2003-03
Primary completion
2008-01
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nadroparin Calcium Other / unclassified
Comparator citrate Unknown

Indications