NCT01516138

Brief Summary

The purpose of this study is to evaluate the effects of modified glucose - insulin - potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
930

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 31, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

January 8, 2012

Last Update Submit

October 30, 2014

Conditions

Cardiac SurgeryCardiopulmonary Bypass

Keywords

Glucose-insulin-potassiumCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Number of participants of the major adverse cardiac events

    The composite of major adverse cardiac events included acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome, congestive heart failure, arrhythmia and all-cause death.

    Stay in hospital

Secondary Outcomes (3)

  • mortality

    until the study ends

  • Length of stay in intensive care unit and hospital

    Stay in intensive care unit and hospital

  • Number of patients of postoperative complications

    Stay in hospital

Other Outcomes (2)

  • Left ventricular ejection fraction (LVEF)

    24h after operation and before discharge

  • Creatine kinase-myocardial bands (CK-MB)

    during 48 h after surgery

Study Arms (2)

GIK

ACTIVE COMPARATOR

glucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl).

Drug: GIK

Control

PLACEBO COMPARATOR

6.12 g/L sodium acetate, 5.85 g/L sodium chloride, 0.3 g/L potassium chloride and 0.33 g/L calcium chloride

Drug: Control

Interventions

GIKDRUG

Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.

Also known as: Glucose-insulin-potassium
GIK
ControlDRUG

Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.

Also known as: Balanced salt solution
Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18 and 70 years of age
  • Elective cardiac surgery with first time cardiopulmonary bypass
  • Left ventricular ejection fraction(LVEF) ≥ 30%
  • Informed agreement signed

You may not qualify if:

  • Previous cardiac surgery
  • Emergent surgery
  • Cardiac surgery without the use of cardiopulmonary bypass
  • Diabetes mellitus
  • Severe renal insufficiency
  • Severe respiratory insufficiency
  • Serious preoperative illness (sepsis, active infection or active malignancy requiring treatment)
  • Pregnant woman or positive pregnancy test
  • History of drug abuse
  • Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
  • Enrollment in another clinical study
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Zhao K, Zhang Y, Li J, Cui Q, Zhao R, Chen W, Liu J, Zhao B, Wan Y, Ma XL, Yu S, Yi D, Gao F. Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass Surgery. J Am Heart Assoc. 2020 Mar 17;9(6):e012376. doi: 10.1161/JAHA.119.012376. Epub 2020 Mar 10.

    PMID: 32151220DERIVED

MeSH Terms

Interventions

glucose-insulin-potassium cardioplegic solutionHanks Balanced Salt Solution

Study Officials

  • Dinghua Yi, MD,PhD

    Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University

    STUDY CHAIR

  • Qin Cui, MD,PhD

    Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

  • Jia Li, MD,PhD

    Deparment of Physiology, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

  • Feng Gao, MD,PhD

    Deparment of Physiology, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

  • Kun Zhao, MD

    Deparment of cardiovascular surgery, XiJing hospital,Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

  • Shiqiang Yu, MD,PhD

    Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2012

First Posted

January 24, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

February 1, 2022

Last Updated

October 31, 2014

Record last verified: 2014-07

Locations

CN(1)