INCEPTION: Intraoperative Dialysis in Liver Transplantation

Sponsor

University of Alberta (Other)

Overall Status

Terminated

CT.gov ID

NCT01575015

Collaborator

(none)

Enrollment

Location

Arms

43.3

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Liver Failure Acute Kidney Disease Multi-organ Failure	Device: Continuous renal replacement therapy (CRRT) Procedure: Standard intraoperative support	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

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)

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Dec 11, 2015

Actual Study Completion Date :

Dec 11, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number 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)]
Will be defined as the proportion of patients adhering to the prescribed protocol.
Number of patients with adverse events [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 [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 [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 [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 [From the date of liver transplant until the date of discharge from ICU/hospital]
Will include ICU and hospital lengths of stay
Mortality [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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