Benefits of GIK in Cardiac Surgery Patients

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Cardiac Surgery; Cardiopulmonary Bypass

Treatments: Drug: GIK; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01516138

XJcuiqin_2012

Details and patient eligibility

About

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).

Full 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.

Enrollment: 930 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

930 participants in 2 patient groups, including a placebo group

GIK

Active Comparator group

Description:

glucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl).

Treatment:

Drug: GIK

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Control