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

NCT ID: NCT03522181

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-30

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.

Conditions

Liver Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

saline

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: OTHER

saline

GIK group

glucose-Insulin-Potassium(GIK) infusion

Group Type: EXPERIMENTAL

Insulin

Intervention Type: OTHER

Interventions

saline

saline

Intervention Type: OTHER

Insulin

Intervention Type: OTHER

Other Intervention Names

glucose-Insulin-Potassium(GIK) infusion

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Ru-Ping Dai

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ru-Ping Dai, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Locations

Department of Anesthesiology, The Second Xiangya Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

XYEYYCT2016214

Identifier Type: -

Identifier Source: org_study_id