The protective effect of hydrogen gas against myocardial ischemia-reperfusion injury in patient undergoing coronary artery bypass surgery with cardiopulmonary bypass

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-ICR-14005495
• Date of registration: 2014-11-09
• Prospective Registration: Yes
• Primary sponsor: Tianjin Medical University General Hospital
• Public title: The protective effect of hydrogen gas against myocardial ischemia-reperfusion injury in patient undergoing coronary artery bypass surgery with cardiopulmonary bypass
• Scientific title: The protective effect of hydrogen gas against myocardial ischemia-reperfusion injury in patient undergoing coronary artery bypass surgery with cardiopulmonary bypass
• Date of first enrolment: 2014-12-01
• Target sample size: CPB group :30;CPB +2%H2 group:30;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=9862
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Clinical pre-test

Countries of recruitment

China

Contacts

• Name: Yonghao Yu

• Name: Lingling Liu
• Affiliation: Tianjin Medical University General Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. The patients undergoing coronary artery bypass surgery with cardiopulmonary bypass operated by the same surgeons;
2. ASA: II-IV;
3. NYHA: II-III;
4. Age: 40-70 years, sex unlimited;
5. The patients who have fully understood the study and signed the informed consent.
Exclusion criteria: 1. History of cardiac surgery or congenital heart disease;
2. Diabetes mellitus;severe hypertension;severe liver dysfunction or kidney dysfunction;history of nervous systeym disease, mental or coagulaton dysfunction;
3. Obesity (BMI greater than 30);
4. History of long-term taking antibiotics or glucocorticoids;history of taking antibiotics, glucocorticoids or free radical scavenger at 1 month preoperatively;
5. Cardiac failure (LVEF less than 30%);severe arrhythmia preoperatively;
6. Combined with inflammatory reponse preopertively (infection, active arthritis or malignant tumor);
7. The patient have involved in clinical tests about other drugs for nearly 4 weeks;
8. The operation time: longer than 8 hours or shoter than 4 hours; the CPB time: longer than 3 hours or shoter than 1 hours; the heart is completely stopped during operation; two or more times CPB in operation; the clinical data is incomplete;
9. The researchers don't think there is any suitable for inclusion for any reason.

Age minimum: 40
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

coronary arteriosclerotic heart disease

Intervention(s)

CPB group :80% oxygen is supplied to the blood by cardiopulmonary bypass machine during CPB;CPB +2%H2 group:the combination of 2% hydrogen gas and 80% oxygen is supplied to the blood by cardiopulmonary bypass machine for 1 hour and then only 80% oxygen is supplied during CPB;

Primary Outcome(s)

Troponin I;Creative kinase-MB;

Secondary Outcome(s)

The concentration of hydrogen gas;Interleukin-6;High mobility group box 1;Superoxide dismutase;Malondialdehyde;NF-kB;

Source(s) of Monetary Support

self-funded