NCT03522181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

December 1, 2016

Last Update Submit

April 30, 2018

Conditions

Liver Transplantation

Outcome Measures

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

    up to 1 weeks

Other Outcomes (5)

  • tracheal extubation

    up to 3 days

  • intensive care unit length of stay and hospital length of stay

    up to 1 month

  • The incidence of complications

    up to 1 month

  • +2 more other outcomes

Study Arms (2)

control group

PLACEBO COMPARATOR

saline

Other: saline

GIK group

EXPERIMENTAL

glucose-Insulin-Potassium(GIK) infusion

Other: Insulin

Interventions

salineOTHER

saline

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who were to undergo OLT

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, The Second Xiangya Hospital

Changsha, Hunan, 410011, China

Location

MeSH Terms

Interventions

Sodium ChlorideInsulin

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Ru-Ping Dai, MD

    Second Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 1, 2016

First Posted

May 11, 2018

Study Start

February 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

May 11, 2018

Record last verified: 2018-04

Locations

CN(1)