A Phase 4 interventional study of CVVH 4 to 2 L/h and CVVH 2 to 4L/h in Kidney, Acute Renal Failure and Multiple Organ Failure, sponsored by Onze Lieve Vrouwe Gasthuis. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-25.
Sponsored by Onze Lieve Vrouwe Gasthuis · Phase 4, Interventional, and Treatment
The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.
Aim of the present study is to determine
The low molecular weight heparin (LMWH) nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. LMWH accumulate in patients with chronic renal failure. Continuous venovenous hemofiltration (CVVH) is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. If not, accumulation is expected and the risk of bleeding for the patient increases. Because critically ill patients are at increased risk of bleeding, this question is crucial.
If nadroparin would be removed by filtration, removal is expected to depend on hemofiltration dose (to be greater with a higher dose)
We therefore designed a randomized controlled cross-over trial in the setting of critical illness and acute renal failure comparing the anticoagulant effect of nadroparin (anti-Xa) between two doses of CVVH in the patients blood, in the extracorporeal circuit and in the ultrafiltrate.
Because hemostasis in critically ill patients is not only influenced by anticoagulation but also by the critical illness and the extracorporeal circuit, we also measure other hemostatic markers, especially the endogenous thrombin potential (ETP), which seems the most global marker of hemostasis, incorporating procoagulant and anticoagulant effects.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 14 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Onze Lieve Vrouwe Gasthuis is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration
Procedure: CVVH 4 to 2 L/h
hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min
Procedure: CVVH 2 to 4L/h
CVVH is initiated at 4L/h and is converted to 2L/h after 60 min
Also known as: continuous venovenous hemofiltration
CVVH is initiated at 2L/h and is converted to 4L/h after 60 min
Also known as: continous venovenous hemofiltration
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.
Time frame: 24 hours
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes
Time frame: 24 hours
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Onze Lieve Vrouwe Gasthuis