Cardiac Surgery, Cardiopulmonary Bypass
Conditions
Keywords
Glucose-insulin-potassium, Cardiac surgery
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.
Interventions
DRUGGIK
Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.
DRUGControl
Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction (LVEF) | 24h after operation and before discharge |
| Creatine kinase-myocardial bands (CK-MB) | during 48 h after surgery |
Countries
China
Outcome results
None listed