Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration
CASH-CVVH
1 other identifier
interventional
139
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2005
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedApril 4, 2013
April 1, 2013
7 years
September 13, 2005
April 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Day 28 after ICU admission
Secondary Outcomes (3)
Laboratory markers of inflammation, endothelial dysfunction and coagulation
72 hours
Filter life (first filter and total amount of filters in 72 hours)
72 hours
Bleeding complications
28 days
Study Arms (2)
heparin
ACTIVE COMPARATORCitrate regional anticoagulation is compared with standard systemic heparinization.
Citrate
ACTIVE COMPARATORregional anticoagulation with citrate containing replacement solution
Interventions
Regional anticoagulation with trisodium citrate is compared with standard systemic heparinization.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Free University Medical Centerlead
- Dirinco B.V.collaborator
Study Sites (9)
Medical Center Alkmaar
Alkmaar, 1815 JD, Netherlands
Slotervaart Ziekenhuis
Amsterdam, 1066 EC, Netherlands
St Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Vrije Universiteit Medical Center
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
UMC Groningen
Groningen, 9713 GZ, Netherlands
Spaarne Hospital Hoofddorp
Hoofddorp, 2134 TM, Netherlands
Rijnland Hospital
Leiderdorp, 2353 GA, Netherlands
Haga Hospital
The Hague, 2545 CH, Netherlands
Related Publications (4)
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. doi: 10.1159/000107045. Epub 2007 Aug 14.
PMID: 17700015BACKGROUNDTsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
PMID: 33314078DERIVEDSchilder L, Nurmohamed SA, Bosch FH, Purmer IM, den Boer SS, Kleppe CG, Vervloet MG, Beishuizen A, Girbes AR, Ter Wee PM, Groeneveld AB; CASH study group. Citrate anticoagulation versus systemic heparinisation in continuous venovenous hemofiltration in critically ill patients with acute kidney injury: a multi-center randomized clinical trial. Crit Care. 2014 Aug 16;18(4):472. doi: 10.1186/s13054-014-0472-6.
PMID: 25128022DERIVEDAman J, Nurmohamed SA, Vervloet MG, Groeneveld AB. Metabolic effects of citrate- vs bicarbonate-based substitution fluid in continuous venovenous hemofiltration: a prospective sequential cohort study. J Crit Care. 2010 Mar;25(1):120-7. doi: 10.1016/j.jcrc.2009.02.013. Epub 2009 May 8.
PMID: 19427760DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Piet M ter Wee, MD, PhD
Amsterdam UMC, location VUmc
- STUDY DIRECTOR
Johan Groeneveld, MD, PhD
Amsterdam UMC, location VUmc
- PRINCIPAL INVESTIGATOR
Shaikh A Nurmohamed, MD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- internist-nephrologist
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2005
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 4, 2013
Record last verified: 2013-04