Clinical trial NCT01516138: Benefits of GIK in Cardiac Surgery Patients
Official title: Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Keywords: Glucose-insulin-potassium
Cardiac surgery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Number of participants of the major adverse cardiac events
timeFrame: Stay in hospital
Secondary outcomes:
measure: mortality
timeFrame: until the study ends
measure: Length of stay in intensive care unit and hospital
timeFrame: Stay in intensive care unit and hospital
measure: Number of patients of postoperative complications
timeFrame: Stay in hospital
Other outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 24h after operation and before discharge
measure: Creatine kinase-myocardial bands (CK-MB)
timeFrame: during 48 h after surgery
Locations:
city: Xi'an
country: China
facility: Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University
name: Dinghua Yi, MD,PhD
role: STUDY_CHAIR
affiliation: Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University
name: Qin Cui, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deparment of Physiology, Fourth Military Medical University
name: Jia Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deparment of Physiology, Fourth Military Medical University
name: Feng Gao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deparment of cardiovascular surgery, XiJing hospital,Fourth Military Medical University
name: Kun Zhao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University
name: Shiqiang Yu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.