Intraoperative Dialysis in Liver Transplantation (INCEPTION)

University of Alberta

Status: Terminated

Conditions: Multi-organ Failure; Liver Failure; Acute Kidney Disease

Treatments: Procedure: Standard intraoperative support; Device: Continuous renal replacement therapy (CRRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01575015

UOFAPro00026047

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Standard intraoperative support (no CRRT)

Active Comparator group

Treatment:

Procedure: Standard intraoperative support

Intraoperative renal support (CRRT)

Experimental group

Treatment:

Device: Continuous renal replacement therapy (CRRT)