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Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

Primary Purpose

Acute Kidney Injury, Liver Disease, Chronic Kidney Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renal replacement therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Continuous Renal Replacement Therapy, Liver Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Chicago Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Renal replacement therapy

No CRRT

Arm Description

Liver transplant recipients who receive continuous renal replacement therapy intra-operatively.

This arm consists of standard of care without CRRT in the OR for OLT

Outcomes

Primary Outcome Measures

Solute Clearance
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

Secondary Outcome Measures

Renal function and patient outcomes
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

Full Information

First Posted
June 12, 2012
Last Updated
May 26, 2015
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01619449
Brief Title
Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant
Official Title
Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Research never begun and no subjects enrolled. Protocol term with IRB in Dec 2014
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
as above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Liver Disease, Chronic Kidney Disease, End Stage Kidney Disease
Keywords
Acute Kidney Injury, Continuous Renal Replacement Therapy, Liver Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal replacement therapy
Arm Type
Experimental
Arm Description
Liver transplant recipients who receive continuous renal replacement therapy intra-operatively.
Arm Title
No CRRT
Arm Type
Active Comparator
Arm Description
This arm consists of standard of care without CRRT in the OR for OLT
Intervention Type
Procedure
Intervention Name(s)
Renal replacement therapy
Intervention Description
Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.
Primary Outcome Measure Information:
Title
Solute Clearance
Description
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
Time Frame
Intra-operative time
Secondary Outcome Measure Information:
Title
Renal function and patient outcomes
Description
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
Time Frame
1 year post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay L Koyner, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

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