Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration

This study has been completed.
Sponsor:
Collaborator:
Gambro Renal Products, Inc.
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00583765
First received: December 20, 2007
Last updated: June 2, 2008
Last verified: June 2008
  Purpose

Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore, researchers are seeking ways to minimize bleeding risks and ensure effective dialysis.

One medication used to thin the blood in the dialysis machine is citrate. Citrate has the advantage of having its blood-thinning properties quickly reversed by calcium in the patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most patients who received citrate for dialysis were administered the citrate in a separate infusion through an IV pump into the dialysis machine. This method requires complex monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very similar to the regular dialysis fluid that is used in this intensive care unit, except that this fluid already contains exactly the correct amount of citrate. Thus, this method does not require a separate pump for citrate and calculations to pump the citrate into the blood as it goes through the kidney machine. Having the citrate already contained in the dialysis fluid simplifies the procedure and reduces the possibility of calculation errors.

This study seeks to determine if this simplified means of providing blood thinning in the kidney machine also results in the correct balance of blood salts.


Condition Intervention
Kidney Failure, Acute
Drug: Regional citrate anticoagulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • metabolic stability [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemofilter survival [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Critically ill patients with acute renal failure requiring continuous renal replacement therapy
Drug: Regional citrate anticoagulation
Continuous venovenous hemodiafiltration with regional anticoagulation using dilute trisodium citrate. This requires the use of a continuous renal replacement therapy (CRRT) machine in venovenous hemodiafiltration mode. Anticoagulation and buffer are provided by the use of a dilute solution of trisodium citrate in the replacement fluid which is infused in a predilution mode. Standard bicarbonate containing dialysate is used.
Other Names:
  • Prismocitrate - the study fluid
  • Prismocal - the commercially available dialysate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Male or female between 17 and 80 years of age.
  2. Critically ill intensive care unit patient.
  3. Renal failure requiring continuous venovenous hemodiafiltration.
  4. Likely to survive for at least 72 hours
Criteria

Inclusion Criteria:

  • Male or female between 17 and 80 years of age.
  • Intensive care unit patient.
  • Acute renal failure requiring continuous venovenous hemodiafiltration.
  • Likely to survive for at least 72 hours

Exclusion Criteria:

  • Age > 80 years
  • Need for systemic anticoagulation, fibrinolytic therapy or activated protein C
  • Acute or chronic hepatic failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583765

Locations
Canada, Alberta
General Systems Intensive Care Unit, University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Noel Gibney, MB BCh BAO University of Alberta
  More Information

Publications:

Responsible Party: R.T.Noel Gibney, Division of Critical Care Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT00583765     History of Changes
Other Study ID Numbers: 5793
Study First Received: December 20, 2007
Last Updated: June 2, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Kidney Failure, Acute
Hemodialysis
Hemofiltration
Anticoagulation
Citrate

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

ClinicalTrials.gov processed this record on April 22, 2014