Clinical trial NCT01794884: Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery
Official title: Intravenous Supplementation of Glutamine Preoperatively for Cardiac Function and Recovery Improvement in Adult Accepting Cardiosurgery: A Randomized, Double-Blinded, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatic Heart Disease
Coronary Heart Disease
Keywords: Glutamine
Cardiosurgery
Cardiopulmonary bypass
Cardiac function
Recovery
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In view of the lack of large-scale clinical study and potent evidence-based medicine, the investigators designed a randomized, double-blind, placebo-controlled study to ascertain whether preoperative intravenous administration with glutamine can improve the postoperative cardiac function and prognosis of adult patients undergoing cardiac surgery. The investigators want to detect the levels of myocardial protein O-GlcNAc modification and HSP70 expression, changes in sensitive indicators of myocardial injury, systemic inflammatory reaction and oxidative stress levels, and to examine the correlation between these changes and Clinical manifestations. The ultimate goal of the study is to explore a new way for clinical myocardial protection.

Detailed description: Cardiosurgery is mostly done under cardiopulmonary bypass. However, the cardiopulmonary bypass and the later recovery of spontaneous circulation, a cardiac ischemia / reperfusion process, may cause myocardial damage and affect cardiac function as well as prognosis.

Glutamine, an amino acid abundant in the human body, plays an important role in the regulation of metabolism and immune cells and the protection of organs. Relative lack of glutamine is reported during stress or serious illness. Animal studies have confirmed that pretreatment with glutamine has a protective effect on the heart, liver, kidney and other organs post ischemia / reperfusion injury. It is also established that glutamine exerts myocardial protection mainly by activating hexosamine biosynthetic pathway, increasing intracellular O-GlcNAc protein modification and expression of heat shock protein 70 (HSP70), starting the protective reaction in the body, improving the function of myocardial cells, and inhibiting the release of inflammatory cytokines and oxidative stress levels. Besides, clinical studies have shown that at the perioperative stage glutamine has a protective effect on cardiac function of the patients treated with pump coronary artery bypass surgery.

The purpose of this study is to ascertain whether preoperative intravenous administration with glutamine (as compared with control group) can improve the postoperative cardiac function and prognosis of adult patients undergoing cardiac surgery and reduce inflammatory response and oxidative stress levels of the body. The correlation between Clinical manifestations and expression of myocardium O-GlcNAc and HSP70 will also be investigated.

Eligibility criteria: Inclusion Criteria:

* Adult patients with coronary artery disease or rheumatic heart disease accepted cardiosurgery under cardiopulmonary bypass

Exclusion Criteria:

* ejection fraction(EF)\<50%
* Preoperative support with intra-aortic balloon pump(IABP)
* Hepatosis
* Renal dysfunction
* Myocardial infarction attack within 3 months
* Emergency operation

Primary outcomes:
measure: perioperative changes of Cardiac Index (CI)
timeFrame: postanescesia before surgery, 2, 20 hours after cardiopulmonary bypass (CPB)
Secondary outcomes:
measure: Troponin I(cTnI)
timeFrame: postanescesia before surgery, 6, 20 hours after CPB
measure: Brain Natriuretic Peptide (BNP)
timeFrame: postanescesia before surgery, 6, 20 hours after CPB
measure: Systemic inflammation
timeFrame: postanescesia before surgery, 2, 20 hours after CPB
measure: Heart issue HSP-70
timeFrame: 20 minutes after CPB
measure: Heart issue O-GlcNAc
timeFrame: 20 minutes after CPB
measure: Recovery index
timeFrame: Date of surgery until date of hospital discharge (an expected average of 2 weeks)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
References: