Back to resultsGlucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation (GIK)
Primary Purpose
Liver Transplantation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
saline
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation
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
Sites / Locations
- Department of Anesthesiology, The Second Xiangya Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
GIK group
Arm Description
saline
glucose-Insulin-Potassium(GIK) infusion
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03522181
First Posted
December 1, 2016
Last Updated
April 30, 2018
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03522181
Brief Title
Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation
Acronym
GIK
Official Title
Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
saline
Arm Title
GIK group
Arm Type
Experimental
Arm Description
glucose-Insulin-Potassium(GIK) infusion
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
saline
Intervention Type
Other
Intervention Name(s)
Insulin
Other Intervention Name(s)
glucose-Insulin-Potassium(GIK) infusion
Primary Outcome Measure Information:
Title
degree of lactic acidosis
Description
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 Pre-specified Outcome Measures:
Title
tracheal extubation
Description
The time of tracheal extubation was calculated.
Time Frame
up to 3 days
Title
intensive care unit length of stay and hospital length of stay
Description
The intensive care unit length of stay and hospital length of stay was calculated
Time Frame
up to 1 month
Title
The incidence of complications
Description
The incidence of complications including liver dysfunction, renal dysfunction, infection, was analyzed
Time Frame
up to 1 month
Title
The incidence of retransplantation
Description
The incidence of liver retransplantation
Time Frame
up to 1 month
Title
The incidence of perioperative mortality
Description
The incidence of perioperative mortality
Time Frame
up to 1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Ping Dai, MD
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, The Second Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation
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