Not provided
Not provided
Not provided
Not provided
Insufficient funding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard intraoperative support (no CRRT) | Active Comparator |
| |
| Intraoperative renal support (CRRT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous renal replacement therapy (CRRT) | Device | Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of patients with post-operative graft dysfunction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sean M Bagshaw, MD, MSc | Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Critical Care Medicine, University of Alberta Hospital | Edmonton | Alberta | T6G2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19109832 | Background | 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. | |
| 21829016 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D012769 | Shock |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079664 | Continuous Renal Replacement Therapy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard intraoperative support | Procedure | Patients allocated to standard intraoperative support will receive usual care (no CRRT). |
|
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) |
| 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 |
| 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 |
| Mortality | Mortality through 90-days. | From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days |
| 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 |
| 31350701 | Derived | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |