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Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Jay Koyner, University of Chicago
ClinicalTrials.gov Identifier:
NCT01619449
First received: June 12, 2012
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Acute Kidney Injury
Liver Disease
Chronic Kidney Disease
End Stage Kidney Disease
 Procedure: Renal replacement therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant: A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Solute Clearance [ Time Frame: Intra-operative time ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    To compare long-term maintenance of renal function (12 months) and other helth outcomes in OLT recipients who received CRRT versus OLT recipients who did not receive OLT


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: 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.

Detailed Description:

as above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619449

Contacts
Contact: Jay Koyner, MD 773-702-4842 jkoyner@medicine.bsd.uchicago.edu
Contact: Amishi Desai, DO 773-702-4844 amishi.desai@uchospitals.edu

Locations
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Jay Koyner, MD     773-702-4842        
Principal Investigator: Jay Koyner, MD            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jay L Koyner, MD University of Chicago
  More Information

No publications provided

Responsible Party: Jay Koyner, Assistant Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01619449     History of Changes
Other Study ID Numbers: IRB #11-0626
Study First Received: June 12, 2012
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Acute Kidney Injury
Continuous Renal Replacement Therapy
Liver Transplant

Additional relevant MeSH terms:
Kidney Diseases
Acute Kidney Injury
Kidney Failure, Chronic
Liver Diseases
 Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013