Intraoperative Dialysis in Liver Transplantation

University of Alberta32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Failure Acute Kidney Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients adhering to the prescribed protocol

Will be defined as the proportion 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)

Number of patients with adverse events

This will be defined by the proportion of patients experiencing intra-operative adverse events, serious adverse events and complications related to the study intervention.

Time frame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)

Secondary Outcomes

Fluid balance

Will be defined as the changes in fluid accumulation intra- and post-operatively.

Time frame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)

Number of patients with post-operative graft dysfunction

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.

Time frame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)

Number of patients with post-operative kidney dysfunction

Will be defined as post-operative acute kidney injury, defined by RIFLE criteria; along with encompassing receipt of renal replacement therapy (RRT).

Time frame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days

Length of stay

Will include ICU and hospital lengths of stay

Time frame: From the date of liver transplant until the date of discharge from ICU/hospital

Mortality

Mortality through 90-days.

Time frame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days

Number of patients readmitted to hospital within 90-days

Will be defined as hospital re-admission within 90-days of liver transplant for any cause.

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