Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation (GIK)

April 30, 2018 updated by: Ru-Ping Dai, Central South University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Department of Anesthesiology, The Second Xiangya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: control group
saline
Other: saline
saline
EXPERIMENTAL: GIK group
glucose-Insulin-Potassium(GIK) infusion
Other: Insulin
Other Names:
  • glucose-Insulin-Potassium(GIK) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of lactic acidosis
Time Frame: 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
up to 1 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
tracheal extubation
Time Frame: up to 3 days
The time of tracheal extubation was calculated.
up to 3 days
intensive care unit length of stay and hospital length of stay
Time Frame: up to 1 month
The intensive care unit length of stay and hospital length of stay was calculated
up to 1 month
The incidence of complications
Time Frame: up to 1 month
The incidence of complications including liver dysfunction, renal dysfunction, infection, was analyzed
up to 1 month
The incidence of retransplantation
Time Frame: up to 1 month
The incidence of liver retransplantation
up to 1 month
The incidence of perioperative mortality
Time Frame: up to 1 month
The incidence of perioperative mortality
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

April 30, 2018

First Posted (ACTUAL)

May 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYEYYCT2016214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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