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Intraoperative Dialysis in Liver Transplantation (INCEPTION)

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ClinicalTrials.gov Identifier: NCT01575015
Recruitment Status : Terminated (Insufficient funding.)
First Posted : April 10, 2012
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Sean M Bagshaw, University of Alberta

March 25, 2012
April 10, 2012
February 7, 2017
May 2012
December 11, 2015   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01575015 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Intraoperative Dialysis in Liver Transplantation
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Failure
  • Acute Kidney Disease
  • Multi-organ Failure
  • Device: Continuous renal replacement therapy (CRRT)
    Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation
  • Procedure: Standard intraoperative support
    Patients allocated to standard intraoperative support will receive usual care (no CRRT).
  • Active Comparator: Standard intraoperative support (no CRRT)
    Intervention: Procedure: Standard intraoperative support
  • Experimental: Intraoperative renal support (CRRT)
    Intervention: Device: Continuous renal replacement therapy (CRRT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
50
December 11, 2015
December 11, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01575015
UOFAPro00026047
No
Not Provided
Not Provided
Sean M Bagshaw, University of Alberta
University of Alberta
Not Provided
Principal Investigator: Sean M Bagshaw, MD, MSc Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta
University of Alberta
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP