Acute Kidney Disease, Liver Failure, Multi-organ Failure
Conditions
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
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.
Interventions
DEVICEContinuous renal replacement therapy (CRRT)
Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation
PROCEDUREStandard intraoperative support
Patients allocated to standard intraoperative support will receive usual care (no CRRT).
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number 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) | Will be defined as the proportion of patients adhering to the prescribed protocol. |
| Number of patients with adverse events | Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours) | This will be defined by the proportion of patients experiencing intra-operative adverse events, serious adverse events and complications related to the study intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Will be defined as post-operative acute kidney injury, defined by RIFLE criteria; along with encompassing receipt of renal replacement therapy (RRT). |
| Length of stay | From the date of liver transplant until the date of discharge from ICU/hospital | Will include ICU and hospital lengths of stay |
| Fluid balance | In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively) | Will be defined as the changes in fluid accumulation intra- and post-operatively. |
| Number of patients readmitted to hospital within 90-days | From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days | Will be defined as hospital re-admission within 90-days of liver transplant for any cause. |
| Mortality | From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days | Mortality through 90-days. |
| 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) | 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. |
Countries
Canada
Outcome results
None listed