Benefits of GIK in Cardiac Surgery Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01516138
First received: January 8, 2012
Last updated: December 27, 2013
Last verified: February 2012

January 8, 2012
December 27, 2013
February 2012
March 2014   (final data collection date for primary outcome measure)
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/cardiogenic shock, arrhythmia and all-cause death.
All cause mortality [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01516138 on ClinicalTrials.gov Archive Site
  • 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 comlications [ Time Frame: Stay in hospital ] [ Designated as safety issue: No ]
    Postoperative complications included prolonged ventilation, requiring epinephrine, sepsis/infection, renal complications and reoperation.
  • Liver/Kidney dysfunction [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]

    Liver dysfunction including jaundice,transaminase elevation 1.5 times more than normal,et al.

    Kidney dysfunction including oliguria,anuria,Cretinine/BUN elevation 1.5 times more than normal,et al.

  • Heart dysfunction [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
    Heart dysfunction including lower cardiac output(CI<2.2L/m2), lower left ventriculus ejection fraction (LVEF<45%) et al.
  • Arrhythmia [ Time Frame: within the first 3 days after surgery ] [ Designated as safety issue: Yes ]
    Arrhythmia including atrial fibrillation, tachycardia, bradycardia,et al.
  • Cumulative cerebrovascular events [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
    Cerebrovascular events as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.
  • Left ventricular ejection fraction (LVEF) [ Time Frame: 24h after operation and before discharge ] [ Designated as safety issue: No ]
  • Creatine kinase myocardial bands (CKMB) [ Time Frame: 24 h and 48 h after operation ] [ Designated as safety issue: No ]
Not Provided
 
Benefits of GIK in Cardiac Surgery Patients
Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

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

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 controvertial results. The beginning time of application, and the ratio of glucose and insulin may be the key cause for the difference. In our pilot trial of 40 valve replacement cases, the investigators found that GIK with high insulin dose showed beneficial effects during heart surgery. Therefore, the investigators are planning to continue to use the GIK with high insulin dose for more heart surgery patients and estimate whether GIK may have cardioprotective effects on patients undergoing heart surgery.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative; Dysfunction Following Cardiac Surgery
  • Cardiopulmonary Bypass
  • Drug: GIK
    Intravenous solution was started at about 10 minutes before general anesthesia and finished eight hours following operation, running at about 60 ml/ h.
    Other Name: Glucose-insulin-potassium
  • Drug: Placebo
    Intravenous solution was started at about 10 minutes before general anesthesia and finished eight hours following operation, running at about 60 ml/ h.
    Other Name: Balanced salt solution
  • Active Comparator: GIK
    glucose-insulin-potassium (GIK) consists of 750 ml of 20% glucose, 50 IU insulin and 45 ml of 10% potassium chloride (KCl)
    Intervention: Drug: GIK
  • Placebo Comparator: Placebo
    750 ml of 4.59 g sodium acetate, 4.39 g sodium chloride, 0.225 g potassium chloride and 0.25 g calcium chloride
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Qin Cui, MD, PhD 86-13809186551 13809186551@126.com
Contact: Jia Li, MD, PhD 86-13892800789 jiali816@fmmu.edu.cn
China
 
NCT01516138
XJcuiqin_2012
Yes
Xijing Hospital
Xijing Hospital
Not Provided
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
Xijing Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP