Benefits of GIK in Cardiac Surgery Patients

Cardiac Surgery Clinical Trial

Official title:

Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01516138
• Other study ID #: XJcuiqin_2012
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 8, 2012
• Last updated: October 30, 2014
• Start date: February 2012
• Est. completion date: February 2022

Study information

• Verified date: July 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 930
• Est. completion date: February 2022
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Left ventricular ejection fraction (LVEF)		24h after operation and before discharge	No
Other	Creatine kinase-myocardial bands (CK-MB)		during 48 h after surgery	No
Primary	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	Yes
Secondary	mortality		until the study ends	No
Secondary	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	No
Secondary	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	No