NCT01575015

Intraoperative Dialysis in Liver Transplantation

Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Failure
• Acute Kidney Disease
• Multi-organ Failure

Interventions

Type	Name	Description
DEVICE	Continuous renal replacement therapy (CRRT)	Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation
PROCEDURE	Standard intraoperative support	Patients allocated to standard intraoperative support will receive usual care (no CRRT).

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-12-11
• Completion: 2015-12-11
• First posted: 2012-04-10
• Last updated: 2017-02-07

Locations

1 site across 1 country: Canada