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

Liver Transplantation Clinical Trial

— GIK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522181
• Other study ID #: XYEYYCT2016214
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Lactic
• Liver Transplantation

Intervention

Other:
• saline
saline
• Insulin

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	tracheal extubation	The time of tracheal extubation was calculated.	up to 3 days
Other	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	up to 1 month
Other	The incidence of complications	The incidence of complications including liver dysfunction, renal dysfunction, infection, was analyzed	up to 1 month
Other	The incidence of retransplantation	The incidence of liver retransplantation	up to 1 month
Other	The incidence of perioperative mortality	The incidence of perioperative mortality	up to 1 month
Primary	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	up to 1 weeks