Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

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• Status: Withdrawn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: Chronic Kidney Disease; Acute Kidney Injury; Liver Disease; End Stage Kidney Disease
• Intervention / Treatment: Procedure: Renal replacement therapy

Detailed Description

as above

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

• Sponsor: University of Chicago

Study record dates

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: Acute Kidney Injury; Liver Transplant; Continuous Renal Replacement Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Renal Insufficiency; Liver Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Acute Kidney Injury
• Other Study ID Numbers: IRB #11-0626