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Intraoperative Dialysis in Liver Transplantation (INCEPTION)

This study has been terminated.
(Insufficient funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01575015
First Posted: April 10, 2012
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean M Bagshaw, University of Alberta
  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
Liver Failure Acute Kidney Disease Multi-organ Failure Device: Continuous renal replacement therapy (CRRT) Procedure: Standard intraoperative support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Sean M Bagshaw, 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) ]
    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) ]
    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) ]
    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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    Will be defined as hospital re-admission within 90-days of liver transplant for any cause.


Enrollment: 32
Study Start Date: May 2012
Study Completion Date: December 11, 2015
Primary Completion Date: December 11, 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575015


Locations
Canada, Alberta
Division of Critical Care Medicine, University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
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 M Bagshaw, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01575015     History of Changes
Other Study ID Numbers: UOFAPro00026047
First Submitted: March 25, 2012
First Posted: April 10, 2012
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Sean M Bagshaw, 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
Urologic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Shock
Pathologic Processes