Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery
Rheumatic Heart Disease
Coronary Heart Disease
Drug: Ringer's solution
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intravenous Supplementation of Glutamine Preoperatively for Cardiac Function and Recovery Improvement in Adult Accepting Cardiosurgery: A Randomized, Double-Blinded, Placebo-Controlled Trial|
- perioperative changes of Cardiac Index (CI) [ Time Frame: postanescesia before surgery, 2, 20 hours after cardiopulmonary bypass (CPB) ] [ Designated as safety issue: No ]For each patient,a Swan-Ganz catheter will be inserted after anesthesia induction.CI and other values of hemodynamics will be measured.
- Troponin I(cTnI) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ] [ Designated as safety issue: No ]CTnI is a sensitive indicator of myocardial damage.
- Brain Natriuretic Peptide (BNP) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ] [ Designated as safety issue: No ]BNP is a sensitive indicator of cardiac dysfunction.
- Systemic inflammation [ Time Frame: postanescesia before surgery, 2, 20 hours after CPB ] [ Designated as safety issue: No ]Blood levels of Interleukin-6（IL-6）、Tumor Necrosis Factor（TNF-a） and Malondialdehyde (MDA) will be measured.
- Heart issue HSP-70 [ Time Frame: 20 minutes after CPB ] [ Designated as safety issue: No ]A mass of heart tissue (a part of right auricle of heart,weigh about 50mg) will be cut 20 minutes after CPB for the measurements.
- Heart issue O-GlcNAc [ Time Frame: 20 minutes after CPB ] [ Designated as safety issue: No ]The same mass of heart tissue described above will be used for the measurements.
- Recovery index [ Time Frame: Date of surgery until date of hospital discharge (an expected average of 2 weeks) ] [ Designated as safety issue: Yes ]Recovery index include duration of mechanical ventilation、duration of ICU stay、duration of hospital stay、adverse event and mortality.
|Study Start Date:||January 2013|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
20% N(2)-L-alanyl-L-glutamine 0.4g/kg(2ml/kg) mixed with compound amino acid (10ml/kg)(volume ratio=1:5).Intravenous injection twice (24 hours、1 hour before operation).
20% N(2)-L-alanyl-L-glutamine 0.4g/kg(2ml/kg) mixed with compound amino acid (10ml/kg).Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h
Other Name: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)
Placebo Comparator: Ringer's solution
Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation).
Drug: Ringer's solution
Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794884
|Zhongda Hospital Southeast University|
|Nanjing, Jiangsu, China, 210009|