Intraoperative Dialysis in Liver Transplantation

NCT01575015 | Terminated

• 1 other identifier: UOFAPro00026047
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Number of patients adhering to the prescribed protocol

  Will be defined as the proportion of patients adhering to the prescribed protocol.

  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.

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

Secondary Outcomes (6)

• Fluid balance

  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

  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

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

• Length of stay

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

• Mortality

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

Study Arms (2)

Standard intraoperative support (no CRRT)

ACTIVE COMPARATOR

Procedure: Standard intraoperative support

Intraoperative renal support (CRRT)

EXPERIMENTAL

Device: Continuous renal replacement therapy (CRRT)

Interventions

Continuous renal replacement therapy (CRRT) DEVICE

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

Intraoperative renal support (CRRT)

Standard intraoperative support PROCEDURE

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

Standard intraoperative support (no CRRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Division of Critical Care Medicine, University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

Related Publications (3)

• 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.

  PMID: 19109832 BACKGROUND

• 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.

  PMID: 21829016 BACKGROUND

• 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.

  PMID: 31350701 DERIVED

MeSH Terms

Conditions

Liver Failure; Multiple Organ Failure

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Sean M Bagshaw, MD, MSc

  Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2012
• First Posted: April 10, 2012
• Study Start: May 1, 2012
• Primary Completion: December 11, 2015
• Study Completion: December 11, 2015
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

CA (1)