Overview

This trial is active, not recruiting.

Conditions cardiac surgery, cardiopulmonary bypass
Treatments gik, control
Phase phase 2
Sponsor Xijing Hospital
Start date February 2012
End date March 2013
Trial size 930 participants
Trial identifier NCT01516138, XJcuiqin_2012

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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).
gik Glucose-insulin-potassium
Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.
(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
control Balanced salt solution
Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.

Primary Outcomes

Measure
Number of participants of the major adverse cardiac events
time frame: Stay in hospital

Secondary Outcomes

Measure
mortality
time frame: until the study ends
Length of stay in intensive care unit and hospital
time frame: Stay in intensive care unit and hospital
Number of patients of postoperative complications
time frame: Stay in hospital

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Principal investigator Qin Cui, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Xijing Hospital.