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Sponsors and Collaborators: |
Free University Medical Center Dirinco BV |
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Information provided by: | Free University Medical Center |
ClinicalTrials.gov Identifier: | NCT00209378 |
The purpose of this study is to compare citrate regional anticoagulation with systemic heparinization in continuous venovenous hemofiltration. The investigators' hypothesis is, that regional citrate anticoagulation with replacement solution containing trisodium citrate, will be associated with lower mortality and less bleeding complications compared to heparin, with also a better filter survival.
Condition | Intervention |
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Kidney Failure |
Other: regional anticoagulation with trisodium citrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration in Critically Ill Patients With Acute Renal Failure: A Randomized Clinical Trial |
Estimated Enrollment: | 350 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Citrate regional anticoagulation is compared with standard systemic heparinization.
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Other: regional anticoagulation with trisodium citrate
Regional anticoagulation with trisodium citrate is compared with standard systemic heparinization.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shaikh A Nurmohamed, MD | 31-20-4444444 ext 6488 | SA.Nurmohamed@vumc.nl |
Contact: Johan Groeneveld, MD, PhD | 31-20-4444444 ext 6068 | Johan.groeneveld@vumc.nl |
Netherlands | |
Rijnstate | Recruiting |
Arnhem, Netherlands | |
Contact: Frank H Bosch, MD, PhD FHBosch@alysis.nl | |
Principal Investigator: Frank H Bosch, MD, PhD | |
St Lucas Andreas Ziekenhuis | Not yet recruiting |
Amsterdam, Netherlands | |
Contact: Carl EH Siegert, MD, PhD C.Siegert@slaz.nl | |
Principal Investigator: Carl EH Siegert, MD, PhD | |
Vrije Universiteit Medical Center | Recruiting |
Amsterdam, Netherlands | |
Contact: Shaikh A Nurmohamed, MD SA.Nurmohamed@vumc.nl | |
Principal Investigator: Shaikh A Nurmohamed, MD | |
Haga Hospital | Recruiting |
The Hague, Netherlands, 2545 CH | |
Contact: Michael Frank, MD m.frank@hagaziekenhuis.nl | |
Principal Investigator: Michael Frank, MD | |
St Franciscus | Recruiting |
Roosendaal, Netherlands, 4708 AE | |
Contact: Harmen Krepel, MD, PhD 00-31-165588000 hkrepel@fzr.nl | |
Principal Investigator: Harmen Krepel, MD, PhD | |
Amphia Hospital | Not yet recruiting |
Breda, Netherlands, 4818 CK | |
Contact: B JM Van der Meer, PhD 00-31-76 595 3000 Bvandermeer@Amphia.nl | |
Principal Investigator: B JM Van der Meer, PhD, MD |
Study Director: | Piet M ter Wee, MD, PhD | VU University Medical Center |
Study Director: | Johan Groeneveld, MD, PhD | VU University Medical Center |
Principal Investigator: | Shaikh A Nurmohamed, MD | VU University Medical Center |
Study ID Numbers: | 03.187 |
Study First Received: | September 13, 2005 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00209378 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Continuous venovenous hemofiltration (CVVH) Continuous renal replacement therapy (CRRT) Regional citrate anticoagulation filter survival |
trisodium citrate bleeding complication Hemofiltration |
Renal Insufficiency Urologic Diseases Critical Illness Citric Acid Kidney Diseases |
Kidney Failure, Acute Hemorrhage Heparin Calcium heparin Kidney Failure |
Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Chelating Agents Pharmacologic Actions |