Intraoperative Glucose Control in Liver Transplant
Recruitment status was Recruiting
The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a randomized, prospective trial.Primary objective: To determine if strict intraoperative blood glucose control, when compared to standard intraoperative glycemic control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Effect Of Intraoperative Strict Glycemic Control During Liver Transplantation On Postoperative Morbidity And Mortality|
- Infection rates and one year survival post transplant [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Hospital length of stay [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Postoperative requirements for blood transfusion within 3 days in the ICU [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Need for and duration of hemodialysis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Incidence of biliary complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Incidence of venous thromboembolic events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
strict glycemic control (80 to 110 mg/dl)
bolus or infusion 80 to 110 mg/dl
No Intervention: 2
standard of care insulin dosing
Approximately 2.1 million patients in the United States acquire infections during medical care every year. For example, 9%-30% patients who undergo surgery acquire nosocomial infections, which increase mortality and morbidity over that expected normally expected and increase the cost of care by several billion dollars. Studies have shown that controlling high blood glucose levels dramatically improves the recovery of critically ill patients after surgery, most notably decreasing the risk of infection. The advantage of strict glycemic control in the critically ill patient is now well accepted, and the Institute for Healthcare Improvement and Surviving Sepsis Campaign set glycemic control as part of the post-operative sepsis management bundle.
Few studies have investigated the role of strict glycemic control during surgery itself. Liver transplantation is a good model for studying glucose control as hyperglycemia almost always occurs and the incidence of infection is higher than with other surgical procedures. We performed a retrospective review of 184 consecutive adult liver recipients in which intra-operative blood glucose levels were measured and treated with insulin. Recipients with strict glycemic control were compared to those with poor control for differences in donor and recipient demographics, intra-operative blood glucose concentrations, intra-operative insulin administered, immunosuppression, post-operative complications, and mortality. Poor glycemic control was associated with a significantly increased rate of infection during the first 30 days post-operatively (48% vs. 33%, P=0.05) and 1-year mortality was significantly increased for those recipients with poor intra-operative glucose control (21.9% vs. 8.8%; P = 0.05). These data along with the post-operative studies, suggest that the post-transplant mortality rate may potentially be decreased by nearly 50% at 1 year and underscore the need for this to be confirmed in a prospective trial.
The goal of this study is to prospectively evaluate the outcomes of liver transplant recipients to either strict glucose control (goal of 80-110 mg/dl) or the current standard of care (goal of between 180 and 200 mg/dl). The specific aim of this study is to determine if strict intra-operative blood glucose control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation. The rates of infection at 30 days after surgery and health at one year post- surgery will be compared. The frequency of other common post-operation complications will also be studied. The proposed study has the potential to have an impact on the intra-operative management of all liver transplant recipients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780026
|Contact: Mary J Maliarik, PhDfirstname.lastname@example.org|
|Contact: Darlene McLean, BA, RNemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Sub-Investigator: Theodore Welling, MD|
|Principal Investigator:||Shawn Pelletier, MD||Universitry of Michigan|