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Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

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ClinicalTrials.gov Identifier: NCT01619449
Recruitment Status : Withdrawn (Research never begun and no subjects enrolled. Protocol term with IRB in Dec 2014)
First Posted : June 14, 2012
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):

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

Detailed Description:
as above

Study Design

Study Type : Interventional  (Clinical Trial)
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 : April 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619449


Locations
United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jay L Koyner, MD University of Chicago
More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01619449     History of Changes
Other Study ID Numbers: IRB #11-0626
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

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

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