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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01575015
Other study ID # UOFAPro00026047
Secondary ID
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
Health authority
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

Study Design


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
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