RCA for CRRT in Liver Failure and High Risk Bleeding Patients

December 31, 2018 updated by: Shiren sun, Air Force Military Medical University, China

The Efficacy and Safety of Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Patients With Liver Failure and High Risk Bleeding: a Randomized, Control, Open-labeled Clinical Trial

The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Liver failure (LF) is a common co-morbidity in critical care patients who need continuous renal replacement therapy (CRRT). Patients with LF are usually associated with impaired coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. KDIGO guideline recommended no-anticoagulation for CRRT in patients with liver failure and increased bleeding risk. However, the averaged CRRT circuit lifespan under no-coagulation was reported to be 7-8 hours in patients with liver failure. Commonly, a CRRT regimen needs more than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure patients underwent no-anticoagulation CRRT. Several observational studies suggested that regional citrate anticoagulation (RCA) during CRRT was effective and safe in patients with liver failure. Therefore, the current opinions on the anticoagulation strategy for CRRT in patients with liver failure and high bleeding risk are controversial. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital of Nephrology
        • Contact:
        • Principal Investigator:
          • Shiren Sun, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Liver failure (acute liver failure and chronic liver failure)
  • High bleeding risk
  • Scheduled CRRT treatment
  • Informed consent

Exclusion Criteria:

  • Use of other anticoagulants
  • Uncorrectable hypoxemia (PaO2 < 60 mmHg) or systemic hypoperfusion shock
  • Pregnancy or lactation
  • Fistula, CRRT treatment time < 12 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No-anticoagulation
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution at the speed of 2 L/h.
Other: No-anticoagulation
Patients accepted CRRT without anticoagulant.
Experimental: Regional citrate anticoagulation

Patients accepted regional citrate anticoagulation. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.

Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+.

Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level.
Other: Regional citrate anticoagulation
Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
Other Names:
  • RCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Filter failure
Time Frame: 72 hours
Filter failure
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypocalcemia
Time Frame: 72 hours
Ionized Ca2+ < 1.0
72 hours
Acidosis
Time Frame: 72 hours
Blood pH < 7.35
72 hours
Serum Total Ca2+/ion Ca2+ level
Time Frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Serum Total Ca2+/ ionized Ca2+ level
2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Alkalosis
Time Frame: 72 hours.
Blood pH > 7.45
72 hours.
Bleeding
Time Frame: 72 hours
Bleeding episode during the CRRT.
72 hours
Serum citrate concentration
Time Frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Citrate concentration
2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Serum total bilirubin level
Time Frame: Every 24 hours up to 72 hours.
Total bilirubin
Every 24 hours up to 72 hours.
Serum AST level
Time Frame: Every 24 hours up to 72 hours.
AST
Every 24 hours up to 72 hours.
Serum ALT level
Time Frame: Every 24 hours up to 72 hours.
ALT
Every 24 hours up to 72 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Study Chair: Shiren Sun, Doctor, Xijing Hospital, the Fourth Military Medical University
  • Principal Investigator: Ming Bai, Doctor, Xijing Hospital, the Fourth Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2018

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

August 30, 2021

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 31, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCA for CRRT in liver failure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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