Intraoperative Dialysis in Liver Transplantation (INCEPTION)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Sean Bagshaw, University of Alberta
ClinicalTrials.gov Identifier:
NCT01575015
First received: March 25, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Liver Failure
Acute Kidney Disease
Multi-organ Failure
Device: Continuous renal replacement therapy (CRRT)
Procedure: Standard intraoperative support
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Will be defined as the proportion of patients adhering to the prescribed protocol.

  • 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) ] [ Designated as safety issue: Yes ]
    This will be defined by the proportion of patients experiencing intra-operative adverse events, serious adverse events and complications related to the study intervention.


Secondary Outcome Measures:
  • Fluid balance [ Time Frame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively) ] [ Designated as safety issue: No ]
    Will be defined as the changes in fluid accumulation intra- and 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Will be defined as post-operative acute kidney injury, defined by RIFLE criteria; along with encompassing receipt of renal replacement therapy (RRT).

  • Length of stay [ Time Frame: From the date of liver transplant until the date of discharge from ICU/hospital ] [ Designated as safety issue: No ]
    Will include ICU and hospital lengths of stay

  • Mortality [ Time Frame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days ] [ Designated as safety issue: No ]
    Mortality through 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 ] [ Designated as safety issue: No ]
    Will be defined as hospital re-admission within 90-days of liver transplant for any cause.


Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575015

Contacts
Contact: Sean Bagshaw 780-407-7448 bagshaw@ualberta.ca
Contact: Samantha Taylor 780-407-7448 samantha.taylor@albertahealthservices.ca

Locations
Canada, Alberta
Division of Critical Care Medicine, University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Sean M Bagshaw    780-492-4698    bagshaw@ualberta.ca   
Contact: Samantha Taylor    780-492-4698    samantha.taylor@albertahealthservices.ca   
Principal Investigator: Sean M Bagshaw         
Sub-Investigator: David Bigam         
Sub-Investigator: Timur Ozelsel         
Sub-Investigator: Constantine Karvellas         
Sub-Investigator: James Shapiro         
Sub-Investigator: Norman Kneteman         
Sub-Investigator: Edward Bishop         
Sub-Investigator: Ron Cheng         
Sub-Investigator: Tim Yeh         
Sub-Investigator: Glenda Meeberg         
Sub-Investigator: Dominic Cave         
Sub-Investigator: Derek Townsend         
Sub-Investigator: Adam Romanovsky         
Sub-Investigator: Noel Gibney         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Sean M Bagshaw, MD, MSc Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta
  More Information

Publications:
Responsible Party: Sean Bagshaw, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01575015     History of Changes
Other Study ID Numbers: UOFAPro00026047
Study First Received: March 25, 2012
Last Updated: July 22, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Liver transplantation (E04.210.650)
Renal replacement therapy (E05.196.353)
Intra-operative period (E04.614.374)
Safety (N06.850.135.060.075)
Efficacy

Additional relevant MeSH terms:
Kidney Diseases
Liver Failure
Multiple Organ Failure
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Pathologic Processes
Shock
Urologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014