Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-05-31

Brief Summary

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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

1. whether nadroparin accumulates in plasma
2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
3. the effects of nadroparin during critical illness on coagulation and anticoagulation

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Detailed Description

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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.

Conditions

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Kidney Acute Renal Failure Multiple Organ Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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hemofiltration at 4L/h

Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration

Group Type ACTIVE_COMPARATOR

CVVH 4 to 2 L/h

Intervention Type PROCEDURE

CVVH is initiated at 4L/h and is converted to 2L/h after 60 min

hemofiltration at 2L/h

hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min

Group Type ACTIVE_COMPARATOR

CVVH 2 to 4L/h

Intervention Type PROCEDURE

CVVH is initiated at 2L/h and is converted to 4L/h after 60 min

Interventions

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CVVH 4 to 2 L/h

CVVH is initiated at 4L/h and is converted to 2L/h after 60 min

Intervention Type PROCEDURE

CVVH 2 to 4L/h

CVVH is initiated at 2L/h and is converted to 4L/h after 60 min

Intervention Type PROCEDURE

Other Intervention Names

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continuous venovenous hemofiltration continous venovenous hemofiltration

Eligibility Criteria

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Inclusion Criteria

* acute renal failure requiring renal replacement therapy

Exclusion Criteria

* (recent) bleeding or a suspicion of bleeding necessitating transfusion,
* need of therapeutic anticoagulation or
* (suspected) heparin-induced thrombocytopenia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No