Intraoperative Glucose Control in Liver Transplant
Condition: Liver Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): insulin
Intervention type(s): Drug
Intervention description(s): bolus or infusion 80 to 110 mg/dl
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: liver; transplant; blood sugar