Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery
Condition: Rheumatic Heart Disease; Coronary Heart Disease
MeSH terms: Rheumatic Heart Disease; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Glutamine; Ringer's solution
Intervention type(s): Drug; Drug
Intervention description(s): 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; Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h.
Other intervention name(s): Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glutamine; Cardiosurgery; Cardiopulmonary bypass; Cardiac function; Recovery