Benefits of GIK in Cardiac Surgery Patients

NCT ID: NCT01516138

Last Updated: 2014-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 930 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2022-02-28

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.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass

Keywords

Glucose-insulin-potassium; Cardiac surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

GIK

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Glucose-insulin-potassium; Balanced salt solution

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dinghua Yi, MD,PhD

Role: STUDY_CHAIR

Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University

Qin Cui, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University

Jia Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Deparment of Physiology, Fourth Military Medical University

Feng Gao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Deparment of Physiology, Fourth Military Medical University

Kun Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Deparment of cardiovascular surgery, XiJing hospital,Fourth Military Medical University

Shiqiang Yu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University

Locations

Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32151220 (View on PubMed)

Other Identifiers

XJcuiqin_2012

Identifier Type: -

Identifier Source: org_study_id