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Completed

NCT Number: NCT03522181

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

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.

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Key information

Conditions

Liver Transplantation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, The Second Xiangya Hospital

Changsha, Hunan, 410011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Other

saline

Insulin

Other

Other names: glucose-Insulin-Potassium(GIK) infusion

Primary outcomes

  1. 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

Other outcomes

  1. tracheal extubation

    Time frame: up to 3 days

    The time of tracheal extubation was calculated.

  2. 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

  3. The incidence of complications

    Time frame: up to 1 month

    The incidence of complications including liver dysfunction, renal dysfunction, infection, was analyzed

  4. The incidence of retransplantation

    Time frame: up to 1 month

    The incidence of liver retransplantation

  5. The incidence of perioperative mortality

    Time frame: up to 1 month

    The incidence of perioperative mortality

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Acronym: GIK

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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