Intraoperative Dialysis in Liver Transplantation (INCEPTION)

February 4, 2017 updated by: Sean M Bagshaw, University of Alberta

Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)

Patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. These patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. As a consequence, these patients are at an increased risk for complications related to their kidney failure during their liver transplantation procedure. One potential method to diminish the risk of these complications is to provide dialysis support to these patients during their liver transplantation in the operating theater in the form of continuous renal replacement therapy (CRRT). While this is increasingly being performed and is theoretically appealing, there is very little information to support this practice. In addition, the use of CRRT during surgery is not entirely without risk. The investigators have performed two preliminary studies on the use of CRRT during liver transplantation and our data would strongly support the need to conduct further higher-quality studies to better evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial comparing the use of CRRT during surgery with standard supportive care in sick patients with liver failure scheduled to receive a liver transplantation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • Division of Critical Care Medicine, University of Alberta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consent
  • Adult (age > 18 years on the day of assessment of eligibility)
  • Planned cadaveric orthotopic liver transplantation
  • Pre-operative unadjusted (natural) Modification of End-Stage Liver Disease (MELD) score > 25.
  • Pre-operative AKI, defined by a minimum RIFLE-RISK, AND/OR pre-operative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.

Exclusion Criteria:

  • Planned living-related donor liver transplantation
  • Pre-operative potassium [K] > 4.5 mmol/L AND urine output < 100 mL in the 6 hrs preceding assessment of eligibility
  • Pre-operative pH < 7.3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard intraoperative support (no CRRT)
Procedure: Standard intraoperative support
Patients allocated to standard intraoperative support will receive usual care (no CRRT).
Experimental: Intraoperative renal support (CRRT)
Device: Continuous renal replacement therapy (CRRT)
Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients adhering to the prescribed protocol
Time Frame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
Will be defined as the proportion of patients adhering to the prescribed protocol.
Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
Number of patients with adverse events
Time Frame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
This will be defined by the proportion of patients experiencing intra-operative adverse events, serious adverse events and complications related to the study intervention.
Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluid balance
Time Frame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Will be defined as the changes in fluid accumulation intra- and post-operatively.
In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Number of patients with post-operative graft dysfunction
Time Frame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Graft dysfunction will include post-operative ultrasonographic-evidence of vascular ischemia/occlusion or venous occlusion; biliary stricture, obstruction or anastomosis leak; primary non-function; biopsy-proven rejection; or need for surgical re-exploration for any reason.
In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Number of patients with post-operative kidney dysfunction
Time Frame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Will be defined as post-operative acute kidney injury, defined by RIFLE criteria; along with encompassing receipt of renal replacement therapy (RRT).
From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Length of stay
Time Frame: From the date of liver transplant until the date of discharge from ICU/hospital
Will include ICU and hospital lengths of stay
From the date of liver transplant until the date of discharge from ICU/hospital
Mortality
Time Frame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Mortality through 90-days.
From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Number of patients readmitted to hospital within 90-days
Time Frame: From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days
Will be defined as hospital re-admission within 90-days of liver transplant for any cause.
From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Sean M Bagshaw, MD, MSc, Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 11, 2015

Study Completion (Actual)

December 11, 2015

Study Registration Dates

First Submitted

March 25, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 4, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOFAPro00026047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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