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

NCT01269112 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2019-08-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-07-31
Completion
2013-11-30

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269112 on ClinicalTrials.gov