Intraoperative Dialysis in Liver Transplantation (INCEPTION)
|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.|
|ClinicalTrials.gov Identifier: NCT01575015|
Recruitment Status : Terminated (Insufficient funding.)
First Posted : April 10, 2012
Last Update Posted : February 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure Acute Kidney Disease Multi-organ Failure||Device: Continuous renal replacement therapy (CRRT) Procedure: Standard intraoperative support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 11, 2015|
|Actual Study Completion Date :||December 11, 2015|
|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
- 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.
- 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.
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
|Division of Critical Care Medicine, University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G2B7|
|Principal Investigator:||Sean M Bagshaw, MD, MSc||Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta|