Protection of Modified Glucose - Insulin - Potassium on the Heart Surgery Patient

This study is currently recruiting participants.
Verified February 2012 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01516138
First received: January 8, 2012
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to evaluate the protective effects of modified glucose - insulin - potassium (MGIK) liquid in patients undergoing cardiopulmonary bypass (CPB).


Condition Intervention
Insulin Resistance
Disorder by Body System or Organ Function
Ischemia-reperfusion Injury
Complication of Extracorporeal Circulation
Drug: Modified glucose - insulin - potassium
Drug: Balanced salt solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Protective Effect of Modified Glucose - Insulin - Potassium on the Cardiac and Other Organs in the Patients With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1000
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modified glucose - insulin - potassium Drug: Modified glucose - insulin - potassium
MGIK group: CPB+MGIK(N=500),receives a MGIK infusion run at 60 ml.h-1 during operation.
Other Name: MGIK
Placebo Comparator: Balanced salt solution Drug: Modified glucose - insulin - potassium
MGIK group: CPB+MGIK(N=500),receives a MGIK infusion run at 60 ml.h-1 during operation.
Other Name: MGIK
Drug: Balanced salt solution
CPB+ BSS(N=500),receives BSS run at 60ml.h-1 during operation
Other Name: BSS

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. GIK was considered as a cardiac energy additive. Opie pointed out that GIK is a drug that cost only a few dollars but gets unexpected result. But the clinical application of GIK shows neutral or negative results too. The beginning time of application, and the ratio of glucose and insulin may be the key cause for the difference.

Harold L. Lazar revealed that modified GIK (high ratio of glucose, 3:1) could promote recovery in patients with coronary artery bypass surgery. Howell NJ and other multicenter clinical study revealed that GIK with high ratio insulin had a greater effect than predicted on the treatment of aortic valve replacement patients.

In our pilot test of 40 valve replacement cases, the investigators also found that GIK with high insulin ratio could reduce stress response and prevent organ damage during heart surgery.

Therefore, the investigators are planning to continue to use the GIK with high insulin ratio for more heart surgery patients and estimate whether GIK could protect the organs in patients undergoing heart surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective CPB surgery
  • Left ventricular ejection fraction(LVEF) ≥ 45%,left ventricular diastolic end diameter(LVDED) ≤ 70mm,Cardiothoracic Ratio(CTR) ≤ 0.70;
  • Informed agreement signed

Exclusion Criteria:

  • History of heart surgery
  • ASA classification = V
  • Severe renal insufficiency defined as SVS risk renal status = 3
  • Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
  • Presence of connective tissue disease
  • Active infection
  • Pregnant woman or positive pregnancy test
  • Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
  • Subject has had a cerebral vascular accident (CVA) within 2 months
  • History of drug abuse
  • Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
  • Enrollment in another clinical study
  • Unwillingness to cooperate with study procedures or follow-up visits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516138

Contacts
Contact: Qin Cui, M.D.,Ph.D 86-13809186551 cuiqin1957@yahoo.com.cn
Contact: Kun Zhao, M.D. 86-13609163626 zhaokun826@gmail.com

Locations
China, Shaanxi
Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Qin Cui, M.D.,Ph.D     86-13809186551     cuiqin1957@yahoo.com.cn    
Principal Investigator: Qin Cui, M.D.,Ph.D            
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Hua D Yi, M.D.,Ph.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Qin Cui, M.D.,Ph.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Kun Zhao, M.D. Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Qiang S Yu, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Sheng W Chen, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Cheng J Liu, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Zhou J Zhang, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Jun Qi Zheng, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Rong Zhao, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Min Chen, M.D. Department of anesthesiology, XiJing hospital, Fourth Military Medical University
Study Director: Ling H LI, M.D Department of UItrasonic Diagnosis, XiJing hospital, Fourth Military Medical University
Study Director: Xiao Z Jin, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Bing H Wang, M.D Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
Study Director: Jun Bi Zhao, M.D 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: February 3, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Insulin Resistance
Ischemia
Reperfusion Injury
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013