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

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ClinicalTrials.gov Identifier: NCT03522181
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ru-Ping Dai, 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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Other: saline Other: Insulin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation
Study Start Date : February 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Placebo Comparator: control group
saline
Other: saline
saline

Experimental: GIK group
glucose-Insulin-Potassium(GIK) infusion
Other: Insulin
Other Name: glucose-Insulin-Potassium(GIK) infusion




Primary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522181


Locations
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China, Hunan
Department of Anesthesiology, The Second Xiangya Hospital
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University
Investigators
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Principal Investigator: Ru-Ping Dai, MD Central South University

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Responsible Party: Ru-Ping Dai, professor, Central South University
ClinicalTrials.gov Identifier: NCT03522181     History of Changes
Other Study ID Numbers: XYEYYCT2016214
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Acidosis
Acidosis, Lactic
Acid-Base Imbalance
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs