Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation

Not Applicable

Completed

• Conditions: Liver Transplantation
• Interventions: Other: saline; Other: Insulin

• Registration Number: NCT03522181
• Lead Sponsor: Central South University

Brief Summary

Lactic acidosis is a common phenomenon occurring during orthotopic liver transplantation (OLT), especially during the anhepatic and early postreperfusion phases. However, little drugs effectively decrease the degree of lactic acidosis when it happens. The aim of this study is to explore whether glucose-Insulin-Potassium(GIK) infusion can relieve metabolic acidosis and improve perioperative outcome in patients undergoing OLT.

Detailed Description

Intraoperative metabolic acidosis begins soon after graft reperfusion and persists for several days. The current standard treatment for severe acidosis during OLT is NaHCO3, although it may compromise myocardial performance, exacerbate lactic acid accumulation and cause central nervous system demyelination. Surgical procedure is a primary source of endogenous lactic acid production, especially visceral ischemia originating from anhepatic stage. The present study thus hypothesized that GIK solution may improve metabolic acidosis in OLT patients through its unique effects of metabolic alleviation. Patients for orthotopic liver transplantation was enrolled and received either GIK or placebo. GIK or placebo infusion started after anesthesia induction. Intraoperative measures were mean arterial pressure, HR, arterial blood gases, lactate, glucose, Na, liver and renal function indexes. Outcome measures were time to tracheal extubation, intensive care unit, length of stay, complications, hospital length of stay, requirement for postoperative plasma transfusion, retransplantation, and perioperative mortality.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-12-01
• Primary Completion: 2017-10
• Study Completion: 2017-11
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-30
• Last Update Submitted: 2018-04-30
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients who were to undergo OLT

Exclusion Criteria

• diabetes mellitus, hyperkalemia on arrival (K+ > 5.5 mEq/L) and the inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	saline	saline
GIK group	Insulin	glucose-Insulin-Potassium(GIK) infusion

Primary Outcome Measures

Name	Time	Method
degree of lactic acidosis	up to 1 weeks	Blood samples for arterial blood pH, PCO2 , PO2 , base excess, hematocrit, and plasma concentrations of lactic acid and Na were analyzed

Trial Locations

Locations (1)

Department of Anesthesiology, The Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China