Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

NCT01619449 | Withdrawn DMC

• 1 other identifier: IRB #11-0626
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury; Liver Disease; Chronic Kidney Disease; End Stage Kidney Disease

Keywords

Acute Kidney Injury; Continuous Renal Replacement Therapy; Liver Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Renal function and patient outcomes

  1 year post-operatively

Study Arms (2)

Renal replacement therapy

EXPERIMENTAL

Liver transplant recipients who receive continuous renal replacement therapy intra-operatively.

Procedure: Renal replacement therapy

No CRRT

ACTIVE COMPARATOR

This arm consists of standard of care without CRRT in the OR for OLT

Procedure: Renal replacement therapy

Interventions

Renal replacement therapy PROCEDURE

Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.

No CRRT; Renal replacement therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pre-operative hemoglobin \< or equal to 7 g/dL
• Pre-operative weight \> or equal to 125 kig

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Liver Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jay L Koyner, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)