Benefits of GIK in Cardiac Surgery Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01516138
First received: January 8, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Cardiac Surgery
Cardiopulmonary Bypass
Drug: GIK
Drug: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Number of participants of the major adverse cardiac events [ Time Frame: Stay in hospital ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30-day and 180-day after operation ] [ Designated as safety issue: No ]
  • Length of stay in intensive care unit and hospital [ Time Frame: Stay in intensive care unit and hospital ] [ Designated as safety issue: No ]
    Length of stay in intensive care unit and hospital

  • Number of patients of postoperative complications [ Time Frame: Stay in hospital ] [ Designated as safety issue: No ]
    Postoperative complications included prolonged ventilation, the use of inotropes, sepsis/infection, renal complications, stroke and reoperation.


Other Outcome Measures:
  • Left ventricular ejection fraction (LVEF) [ Time Frame: 24h after operation and before discharge ] [ Designated as safety issue: No ]
  • Creatine kinase-myocardial bands (CK-MB) [ Time Frame: during 48 h after surgery ] [ Designated as safety issue: No ]

Enrollment: 930
Study Start Date: February 2012
Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GIK
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
Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.
Other Name: Glucose-insulin-potassium
Placebo Comparator: Control
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
Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.
Other Name: Balanced salt solution

Detailed Description:

Cardiopulmonary bypass (CPB) is a necessary technique to maintain the circulation during cardiac surgery. But CPB itself is associated with a series of problems of organs, such as hyperglycemia induced by neuroendocrine stress. The research showed that hyperglycemia induced by stress would cause a worsened hospital outcome for patients undergoing cardiac surgery. Intraoperative and postoperative glucose control is beneficial for patients.

It has been for more than 40 year since the first application of glucose - insulin - potassium (GIK) in cardiac surgery but the clinical application of GIK shows controversial results. The beginning time of application and the ratio of glucose and insulin may be the key reasons for the controversy. In our pilot trial of 40 valve replacement cases, we found that perioperative treatment of GIK with an insulin-glucose ratio of 1:3 showed beneficial effects during heart surgery. Therefore, the investigators are planning to continue to test this modified GIK regimen for more heart surgery patients and determine whether GIK may have cardioprotective effects on patients undergoing CPB surgery.

Myocardial biopsies for biological mechanism analysis will be performed prior to CPB, 15 min after aortic cross clamp application and 15 min after reperfusion only in a small cohort. Myocardial biopsies will be snap frozen or fixed.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516138

Locations
China, Shaanxi
Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Dinghua Yi, MD,PhD Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01516138     History of Changes
Other Study ID Numbers: XJcuiqin_2012
Study First Received: January 8, 2012
Last Updated: July 15, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Glucose-insulin-potassium
Cardiac surgery

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014