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Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01269112
First received: January 3, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding.

The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.


Condition Intervention Phase
- Effectiveness Ofcitrate-based Regional Anticoagulation in Renal Replacement Therapy .
 Device: citrate regional anticoagulation
Device: citrate regional anticoagulation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Mean daily dialysis delivered dose during intensive care stay [ Time Frame: dialysis days during intensive care stay ] [ Designated as safety issue: No ]
    • Mean daily delivered dose during intensive care stay
    • Filter life span


Secondary Outcome Measures:
  • patient survival [ Time Frame: 28-day and 90-day patient survivals ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 190
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: heparin Device: citrate regional anticoagulation

Patients randomly allocated to 2 treatment groups:

Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation

Device: citrate regional anticoagulation

Patients randomly allocated to 2 treatment groups:

Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation
Active Comparator: citrate regional anticoagulation Device: citrate regional anticoagulation

Patients randomly allocated to 2 treatment groups:

Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute kidney injury requiring renal replacement therapy (RIFLE criteria)
  • Patients (males or females) > 18 yrs old
  • Consent form signed (or in emergency investigator's statement form)

Exclusion Criteria:

  • Patients with active bleeding disorders
  • Patients with past history of heparin-induced thrombocytopenia (HIT)
  • Patients with very severe liver disease ( patients awaiting liver transplant or factor V < 20% or MELD score > 25)
  • Pregnancy (negative pregnancy test required in child-bearing age women prior to inclusion)
  • Enrollment in another concurrent therapeutic trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269112

Contacts
Contact: Patrick Saudan, MD 412237296764 Patrick.Saudan@hcuge.ch

Locations
Switzerland
University Hospitals of Geneva Recruiting
Geneva, Switzerland, 1211
Contact: Patrick Saudan, MD     41223729764     Patrick.Saudan@hcuge.ch    
Principal Investigator: Patrick Saudan, MD            
Sponsors and Collaborators
University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Dr Patrick Saudan, MD, Nephrology Unit, University hospitals of Geneva
ClinicalTrials.gov Identifier: NCT01269112     History of Changes
Other Study ID Numbers: 09-069(NAC 09-27)
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
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 22, 2013