Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

Sponsor

University of Chicago (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01619449

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Liver Disease Chronic Kidney Disease End Stage Kidney Disease	Procedure: Renal replacement therapy	N/A

Detailed Description

as above

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Solute Clearance [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

Secondary Outcome Measures

Renal function and patient outcomes [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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