Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration
Information source: Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Acute
Intervention: trisodium citrate (Drug); nadroparin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Onze Lieve Vrouwe Gasthuis Official(s) and/or principal investigator(s): Heleen M Oudemans-van Straaten, MD,PhD, Principal Investigator, Affiliation: Onze Lieve Vrouwe Gasthuis
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.
Clinical Details
Official title: Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration, a Randomized Controlled Trial Comparing Anticoagulation With Citrate to the Low Molecular Weight Heparin Nadroparin
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: bleeding complicationstransfusion requirement filter survival
Secondary outcome: mortality
Detailed description:
Severely ill patients admitted to the intensive care unit may develop an acute failure of
kidney function. Renal function generally recovers if the acute illness improves. To bridge
this period, renal function is temporarily replaced by continuous hemofiltration, so called
continuous venovenous hemofiltration (CVVH). To remove toxic substances and fluids, the
patient's blood flows through a circuit, containing a filter. Flow in the filter is
regulated by the CVVH-device.
Normally blood starts to clot as soon as it leaves the body. To prevent clotting of the
blood in the filter, the blood has to be 'anticoagulated'. For this purpose, heparins are
generally used. Heparins make the blood less likely to clot. Drawback of the use of heparins
is that they not only prevent clotting of blood in the circuit and the filter, but also in
the patient. Heparins thereby increase the risk of bleeding. Intensive care patients are at
higher risk of bleeding due to a recent operation or trauma, ulcers in the mouth or the
stomach, or abnormalities in their blood to the acute illness. Due to the continuous
application of CVVH for days, anticoagulation is administered without interruption over
prolonged periods of time. Studies report bleeding complications in 5 to 50% of the
patients. As a result of bleeding, patients need blood transfusion and sometimes surgery.
Control of bleeding is sometimes extremely difficult.
An alternative to heparin is citrate, which allows regional anticoagulation of the circuit
and the filter without an effect increasing the risk of bleeding for the patient.
Anticoagulation with citrate is more complex, nurses need to follow a strict protocol..
Several small studies have shown that regional anticoagulation with citrate is associated
with less bleeding and a longer filter survival. The use if citrate is however associated
with a greater risk of metabolic complications, if the protocol is not strictly followed.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Intensive care patients scheduled for continuous venovenous hemofiltration
Exclusion Criteria:
- Severe pre-existent liver failure (cirrhosis Child C), acute liver dysfunction as
occurring with septic shock is not a reason for exclusion
- Active bleeding or bleeding necessitating the infusion of two red blood cell units
within 24 hours before starting hemofiltration or a fall in hemoglobin of > 0. 5
mmol/l. A fall in hemoglobin/hematocrit as a result of fluid loading is not regarded
as bleeding.
- Surgery within 24 h prior to CVVH.
- Patients needing full systemic anticoagulation (unfractionated heparin in a dose of >
10000 IU/day, or nadroparin > 3800 IU/day) for other reasons
- Expectation to die within 24 hours
- Chronic dialysis
- Proven or suspected heparin-induced thrombocytopenia
Locations and Contacts
Onze Lieve Vrouwe Gasthuis, Amsterdam 1090HM, Netherlands
Additional Information
Starting date: March 2003
Last updated: August 25, 2009
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