Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

May 26, 2015 updated by: University of Chicago

Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant: A Randomized Trial

To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters. The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is associated with increased solute removal and improved acid-base statues when compared to controls who do not receive CRRT

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

as above

Study Type

Interventional

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 Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older and able to sign consent (or surrogate)
  • Receiving liver or combined liver-kidney transplant
  • eGFR < or equal to 40 ml/min immediately prior to transplant or currently on any form of renal replacement therapy for acute kidney injury or end-stage renal disease
  • Pre-operative potassium of < or equal to 5.5 mEq/L

Exclusion Criteria:

  • Pre-operative hemoglobin < or equal to 7 g/dL
  • Pre-operative weight > or equal to 125 kig

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
Experimental: Renal replacement therapy
Liver transplant recipients who receive continuous renal replacement therapy intra-operatively.
Procedure: Renal replacement therapy
Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.
Active Comparator: No CRRT
This arm consists of standard of care without CRRT in the OR for OLT
Procedure: Renal replacement therapy
Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Solute Clearance
Time Frame: Intra-operative time
To compare the clearance of solutes (ie. potassium, lactate, creatinine and blood urea nitrogen) by CRRT in renally impaired OLT recipients to OLT recipients who do not receive CRRT
Intra-operative time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function and patient outcomes
Time Frame: 1 year post-operatively
To compare long-term maintenance of renal function (12 months) and other health outcomes in OLT recipients who received CRRT versus OLT recipients who did not receive OLT
1 year post-operatively

Collaborators and Investigators

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

Sponsor

University of Chicago

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

April 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 14, 2012

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #11-0626

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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