Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01619449
• Other study ID #: IRB #11-0626
• Status: Withdrawn
• Phase: N/A
• First received: June 12, 2012
• Last updated: May 26, 2015
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

as above

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease
• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Liver Disease
• Liver Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Renal replacement therapy
Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No