Clinical trial NCT01575015: Intraoperative Dialysis in Liver Transplantation
Official title: Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Failure
Acute Kidney Disease
Multi-organ Failure
Keywords: Liver transplantation (E04.210.650)
Renal replacement therapy (E05.196.353)
Intra-operative period (E04.614.374)
Safety (N06.850.135.060.075)
Efficacy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of patients adhering to the prescribed protocol
timeFrame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
measure: Number of patients with adverse events
timeFrame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
Secondary outcomes:
measure: Fluid balance
timeFrame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
measure: Number of patients with post-operative graft dysfunction
timeFrame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
measure: Number of patients with post-operative kidney dysfunction
timeFrame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
measure: Length of stay
timeFrame: From the date of liver transplant until the date of discharge from ICU/hospital
measure: Mortality
timeFrame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
measure: Number of patients readmitted to hospital within 90-days
timeFrame: From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Division of Critical Care Medicine, University of Alberta Hospital
state: Alberta
Study officials:
affiliation: Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta
name: Sean M Bagshaw, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Townsend DR, Bagshaw SM, Jacka MJ, Bigam D, Cave D, Gibney RT. Intraoperative renal support during liver transplantation. Liver Transpl. 2009 Jan;15(1):73-8. doi: 10.1002/lt.21650.
citation: Parmar A, Bigam D, Meeberg G, Cave D, Townsend DR, Gibney RT, Bagshaw SM. An evaluation of intraoperative renal support during liver transplantation: a matched cohort study. Blood Purif. 2011;32(3):238-48. doi: 10.1159/000329485. Epub 2011 Aug 9.
citation: Karvellas CJ, Taylor S, Bigam D, Kneteman NM, Shapiro AMJ, Romanovsky A, Gibney RTN, Townsend DR, Meeberg G, Ozelsel T, Bishop E, Bagshaw SM. Intraoperative continuous renal replacement therapy during liver transplantation: a pilot randomized-controlled trial (INCEPTION). Can J Anaesth. 2019 Oct;66(10):1151-1161. doi: 10.1007/s12630-019-01454-0. Epub 2019 Jul 26.