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CompletedNCT03522181GIKUpdated May 11, 2018

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

An interventional study of saline and Insulin in Liver Transplantation, sponsored by Central South University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2018-05-11.

Sponsored by Central South University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Liver Transplantation
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In context

Acidosis

194 studies on the registry are indexed under Acidosis; 31 are open to participants now.

This study's enrollment of 80 is above the median of 53 across 124 interventional studies indexed under Acidosis.

Browse Acidosis studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients who were to undergo OLT

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Placebo comparator
    control group

    saline

    Other: saline

  • Experimental
    GIK group

    glucose-Insulin-Potassium(GIK) infusion

    Other: Insulin

Interventions

  • Othersaline

    saline

  • OtherInsulin

    Also known as: glucose-Insulin-Potassium(GIK) infusion

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What researchers measure

Primary outcomes

  1. degree of lactic acidosis

    Blood samples for arterial blood pH, PCO2 , PO2 , base excess, hematocrit, and plasma concentrations of lactic acid and Na were analyzed

    Time frame: up to 1 weeks

Other outcomes

  1. tracheal extubation

    The time of tracheal extubation was calculated.

    Time frame: up to 3 days

  2. intensive care unit length of stay and hospital length of stay

    The intensive care unit length of stay and hospital length of stay was calculated

    Time frame: up to 1 month

  3. The incidence of complications

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

    Time frame: up to 1 month

  4. The incidence of retransplantation

    The incidence of liver retransplantation

    Time frame: up to 1 month

  5. The incidence of perioperative mortality

    The incidence of perioperative mortality

    Time frame: up to 1 month

07

Study locations

1 site
  • Department of Anesthesiology, The Second Xiangya Hospital
    Changsha, Hunan 410011, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03522181
Lead sponsor
Central South University
Responsible party
Ru-Ping Dai (professor, Central South University) — Principal investigator
First posted
May 11, 2018
Start date
Feb 2016
Primary completion
Oct 2017
Completion
Nov 2017
Last update
May 11, 2018

Study contacts

Ru-Ping Dai, MD
principal investigator · Central South University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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