Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01619449
First received: June 12, 2012
Last updated: September 4, 2013
Last verified: June 2012

June 12, 2012
September 4, 2013
April 2012
April 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01619449 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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

as above

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Kidney Injury
  • Liver Disease
  • Chronic Kidney Disease
  • End Stage Kidney Disease
Procedure: Renal replacement therapy
Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.
  • Experimental: Renal replacement therapy
    Liver transplant recipients who receive continuous renal replacement therapy intra-operatively.
    Intervention: Procedure: Renal replacement therapy
  • Active Comparator: No CRRT
    This arm consists of standard of care without CRRT in the OR for OLT
    Intervention: Procedure: Renal replacement therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Jay Koyner, MD 773-702-4842 jkoyner@medicine.bsd.uchicago.edu
Contact: Amishi Desai, DO 773-702-4844 amishi.desai@uchospitals.edu
United States
 
NCT01619449
IRB #11-0626
Yes
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Jay L Koyner, MD University of Chicago
University of Chicago
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP