Intraoperative glycemic control in patients undergoing Orthotopic liver transplant: a single center prospective randomized study

Abstract

Background: Perioperative hyperglycemia is associated with poor outcomes yet evidence to guide intraoperative goals and treatment modalities during non-cardiac surgery are lacking. End-stage liver disease is associated with altered glucose homeostasis; patients undergoing liver transplantation display huge fluctuations in blood glucose (BG) and represent a population of great interest. Here, we conduct a randomized trial to compare the effects of strict versus conventional glycemic control during orthotopic liver transplant (OLT). Methods: Following approval by the Institutional Review Board of the University of Michigan Medical School and informed consent, 100 adult patients undergoing OLT were recruited. Patients were randomized to either strict (target BG 80-120 mg/dL) or conventional (target BG 180-200 mg/dL) BG control with block randomization for diabetic and nondiabetic patients. The primary outcomes measured were 1-year patient and graft survival assessed on an intention to treat basis. Graft survival is defined as death or needing re-transplant (www.unos.org). Three and 5-year patient and graft survival, infectious and biliary complications were measured as secondary outcomes. Data were examined using univariate methods and Kaplan-Meir survival analysis. A sensitivity analysis was performed to compare patients with a mean BG of ≤120 mg/dL and those > 120 mg/dL regardless of treatment group. Results: There was no statistically significant difference in patient survival between conventional and strict control respectively;1 year, 88% vs 88% (p-0.99), 3 years, 86% vs 84% (p-0.77), 5 years, 82% vs 78. % (p-0.36). Graft survival was not different between conventional and strict control groups at 1 year, 88% vs 84% (p-0.56), 3 years 82% vs 76% (p-0.46), 5 years 78% vs 70% (p-0.362). Conclusion: There was no difference in patient or graft survival between intraoperative strict and conventional glycemic control during OLT. Trial registration: Clinical trial number and registry: www.clinicaltrials.gov NCT00780026. This trial was retrospectively registered on 10/22/2008.

Perioperative intensive glycemic control for liver transplant recipients to prevent surgical site infection: A systematic review and meta‐analysis

“…Men were over represented in each of the five studies with 411 out of all 604 study participants being male. Hepatitis C virus, 22,40 Hepatitis B virus, 41 and alcoholrelated cirrhosis, 21 were the main indications for liver transplant. The model of end-stage liver disease (MELD) score for participants in the RCTs ranged from 19 to 28 and was slightly lower in the cohort studies ranging from 13 to 19.…”

“…Intravenous insulin (rapid-acting or analogue) was used in both trials for both groups. 21,22 Among the cohort studies, blood glucose readings in two studies were performed by analyzing arterial blood samples and managing glucose levels with intravenous insulin. 40,41 In the third cohort study,…”

“…19 Beginning in the pre-admission ward or operating theater, patients' blood glucose levels are checked hourly using either finger prick devices or venous or arterial blood samples. [20][21][22] Protocols using sliding scales aim to reach target blood glucose levels using subcutaneous or intravenous rapid-acting insulin (or insulin analogue). The short half-life of insulin allows efficient adjustments.…”

“…32 This update states RCTs evaluating lower glucose target levels were not found. However, several recently published studies propose lower targeted levels 20,21,24 and a systematic review including 2836 patients having cardiac, gastrectomy, major non-cardiac surgery, or neurological procedures, showed a 57% reduction in risk of SSI among patients having intensive glycemic control compared to those having standard control. 18 The majority of studies into glycemic control focus on patients having cardiac surgery and while this is a major surgical procedure similar to liver transplant surgery, the recommendations based upon cardiac and other surgical patients may not be generalizable to liver transplant surgery patients.…”

“…8,15 Some studies of intensive glycemic control among liver transplant recipients to prevent SSIs exist, although they have found contradictory results. 21,22,33 Therefore, the primary objective of this review is to determine if intensive glycemic control, compared with standard glycemic control, is more effective in reducing SSIs among liver transplant recipients.…”