Intraoperative Dialysis in Liver Transplantation

Liver Failure Clinical Trial

— INCEPTION  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01575015
• Other study ID #: UOFAPro00026047
• Status: Terminated
• Phase: N/A
• First received: March 25, 2012
• Last updated: February 4, 2017
• Start date: May 2012
• Est. completion date: December 11, 2015

Study information

• Verified date: February 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 11, 2015
• Est. primary completion date: December 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Disease
• Kidney Diseases
• Liver Failure
• Multi-organ Failure
• Multiple Organ Failure

Intervention

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).

Locations

Country	Name	City	State
Canada	Division of Critical Care Medicine, University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Fluid balance	Will be defined as the changes in fluid accumulation intra- and post-operatively.	In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Secondary	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.	In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Secondary	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).	From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Secondary	Length of stay	Will include ICU and hospital lengths of stay	From the date of liver transplant until the date of discharge from ICU/hospital
Secondary	Mortality	Mortality through 90-days.	From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Secondary	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.	From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days