Intraoperative Dialysis in Liver Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Failure Acute Kidney Disease Multi-organ Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard intraoperative support (no CRRT)

Group Type ACTIVE_COMPARATOR

Standard intraoperative support

Intervention Type PROCEDURE

Patients allocated to standard intraoperative support will receive usual care (no CRRT).

Intraoperative renal support (CRRT)

Group Type EXPERIMENTAL

Continuous renal replacement therapy (CRRT)

Intervention Type DEVICE

Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation

Interventions

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Continuous renal replacement therapy (CRRT)

Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation

Intervention Type DEVICE

Standard intraoperative support

Patients allocated to standard intraoperative support will receive usual care (no CRRT).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No