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

This study has been completed.
Sponsor:
Collaborator:
Dirinco B.V.
Information provided by (Responsible Party):
S.A. Nurmohamed, Free University Medical Center
ClinicalTrials.gov Identifier:
NCT00209378
First received: September 13, 2005
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  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
Acute Kidney Injury
 Other: regional anticoagulation with citrate
Other: HfCitPre

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration in Critically Ill Patients With Acute Renal Failure: A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by Free University Medical Center:

Primary Outcome Measures:
  • Mortality [ Time Frame: Day 28 after ICU admission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Laboratory markers of inflammation, endothelial dysfunction and coagulation [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Filter life (first filter and total amount of filters in 72 hours) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Bleeding complications [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 139
Study Start Date: May 2005
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: heparin
Citrate regional anticoagulation is compared with standard systemic heparinization.
 Other: regional anticoagulation with citrate
Regional anticoagulation with trisodium citrate is compared with standard systemic heparinization.
Other Name: HFCitPre
Active Comparator: Citrate
regional anticoagulation with citrate containing replacement solution
 Other: HfCitPre
regional anticoagulation with citrate containing replacement solution
Other Name: HfCitPre

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 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 80 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

Locations
Netherlands
Medical Center Alkmaar
Alkmaar, Netherlands, 1815 JD
St Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Vrije Universiteit Medical Center
Amsterdam, Netherlands
Slotervaart Ziekenhuis
Amsterdam, Netherlands, 1066 EC
Rijnstate
Arnhem, Netherlands
UMC Groningen
Groningen, Netherlands, 9713 GZ
Spaarne Hospital Hoofddorp
Hoofddorp, Netherlands, 2134 TM
Rijnland Hospital
Leiderdorp, Netherlands, 2353 GA
Haga Hospital
The Hague, Netherlands, 2545 CH
Sponsors and Collaborators
Free University Medical Center
Dirinco B.V.
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: S.A. Nurmohamed, internist-nephrologist, Free University Medical Center
ClinicalTrials.gov Identifier: NCT00209378     History of Changes
Other Study ID Numbers: 03.187
Study First Received: September 13, 2005
Last Updated: April 1, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Free University Medical Center:
Continuous venovenous hemofiltration (CVVH)
Continuous renal replacement therapy (CRRT)
Acute Kidney Injury
Regional citrate anticoagulation
 filter survival
trisodium citrate
bleeding complication
Hemofiltration

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Citric Acid
Heparin
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013