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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Saudan, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01269112
First received: January 3, 2011
Last updated: May 12, 2016
Last verified: May 2016
  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
Acute Kidney Injury
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:


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 ]

Enrollment: 103
Study Start Date: November 2010
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: heparin
CVVHDF performed using unfractionated heparin as anticoagulant and Prismasol as reinjection and dialysate fluids
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
CVVHDF performed using Prismocitrate 18/0 solution (Trisodium citrate 18 mmol/L
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


Detailed Description:

monocentric prospective open-label randomized controlled trial at the ICU of the University Hospitals of Geneva (Switzerland).

ICU patients eligible if they 18 yr old and had an AKI requiring CRRT Exclusion criteria Patients excluded if they had active hemorrhagic disorders or severe thrombocytopenia (< 50x109/L), a history of heparin-induced thrombocytopenia, severe liver failure defined as a factor V <20% or were on the waiting list for liver transplantation.

Treatment assignment Subjects enrolled into the trial randomly allocated to either heparin or citrate anticoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01269112

Locations
Switzerland
University Hospitals of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick Saudan, PD Dr Patrick Saudan, MD, University Hospital, 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: May 12, 2016
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Citric Acid
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Calcium Chelating Agents
Chelating Agents
Sequestering Agents

ClinicalTrials.gov processed this record on August 29, 2016