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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIK | Active Comparator | glucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl). |
|
| Control | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIK | Drug | Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants of the major adverse cardiac events | 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. | Stay in hospital |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | until the study ends | |
| Length of stay in intensive care unit and hospital | Length of stay in intensive care unit and hospital | Stay in intensive care unit and hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | 24h after operation and before discharge | |
| Creatine kinase-myocardial bands (CK-MB) | during 48 h after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dinghua Yi, MD,PhD | Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32151220 | Derived | 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. |
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| ID | Term |
|---|---|
| C030396 | glucose-insulin-potassium cardioplegic solution |
| C072670 | Hanks Balanced Salt Solution |
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| Control | Drug | Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours. |
|
|
| Number of patients of postoperative complications | Postoperative complications included prolonged ventilation, the use of inotropes, sepsis/infection, renal complications, stroke and reoperation. | Stay in hospital |