Benefits of GIK in Cardiac Surgery Patients
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Number of participants of the major adverse cardiac events [Stay in hospital]
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 [until the study ends]
- Length of stay in intensive care unit and hospital [Stay in intensive care unit and hospital]
Length of stay in intensive care unit and hospital
- Number of patients of postoperative complications [Stay in hospital]
Postoperative complications included prolonged ventilation, the use of inotropes, sepsis/infection, renal complications, stroke and reoperation.
Other Outcome Measures
- Left ventricular ejection fraction (LVEF) [24h after operation and before discharge]
- Creatine kinase-myocardial bands (CK-MB) [during 48 h after surgery]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJcuiqin_2012