Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration - Full Text View

Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration (CASH-CVVH)

This study is currently recruiting participants.

Verified by Free University Medical Center, November 2007

Sponsors and Collaborators:	Free University Medical Center Dirinco BV
Information provided by:	Free University Medical Center
ClinicalTrials.gov Identifier:	NCT00209378

Purpose

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
Kidney Failure	Other: regional anticoagulation with trisodium citrate

MedlinePlus related topics: Blood Thinners Kidney Failure

Drug Information available for: Citric acid Sodium Citrate Heparin

U.S. FDA Resources

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

Further study details as provided by Free University Medical Center:

Primary Outcome Measures:

Mortality [ Time Frame: Day 28 after ICU admission ]
Filter life (first filter and total amount of filters in 72 hours) [ Time Frame: 72 hours ]
Bleeding complications [ Time Frame: Observation period ]

Secondary Outcome Measures:

Laboratory markers of inflammation, endothelial dysfunction and coagulation [ Time Frame: 72 hours ]

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.	Other: regional anticoagulation with trisodium citrate Regional anticoagulation with trisodium citrate is compared with standard systemic heparinization.

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Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients admitted on the Intensive Care Unit (ICU) requiring continuous venovenous hemofiltration.
No high bleeding risk. A high bleeding risk is defined as a platelet count below 40 x 10^9/L or APTT of more than 60 seconds or a PT-INR of more than 2.0 or a recent major bleeding or significant active bleeding i.e. requirement for more than two units of packed red blood cells as a transfusion within 24 hours of initiation of CVVH.

Exclusion Criteria:

Less than 18 or over 75 years of age.
Patients administered heparin or coumarins for other reasons will also be excluded.
Patients with a HIT in known history will also be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209378

Contacts

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

Locations

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

Sponsors and Collaborators

Free University Medical Center

Dirinco BV

Investigators

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

More Information

Publications:

Nurmohamed SA, Vervloet MG, Girbes AR, Ter Wee PM, Groeneveld AB. Continuous venovenous hemofiltration with or without predilution regional citrate anticoagulation: a prospective study. Blood Purif. 2007;25(4):316-23. Epub 2007 Aug 14.

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)

Keywords provided by Free University Medical Center:

Continuous venovenous hemofiltration (CVVH)
Continuous renal replacement therapy (CRRT)
Regional citrate anticoagulation
filter survival

trisodium citrate
bleeding complication
Hemofiltration

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Critical Illness
Citric Acid
Kidney Diseases

Kidney Failure, Acute
Hemorrhage
Heparin
Calcium heparin
Kidney Failure

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009