Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery

This study is currently recruiting participants.
Verified February 2014 by Southeast University, China
Sponsor:
Information provided by (Responsible Party):
Yuejiang Liu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01794884
First received: February 4, 2013
Last updated: February 28, 2014
Last verified: February 2014

February 4, 2013
February 28, 2014
January 2013
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01794884 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Blood concentration of Gln [ Time Frame: postanescesia before surgery, 2, 20 hours after CPB ] [ Designated as safety issue: No ]
    We want to be sure that the blood concentration of Gln was increased compared to the control group after intravenous glutamine supplementation.
  • 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.
Not Provided
Not Provided
 
Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery
Intravenous Supplementation of Glutamine Preoperatively for Cardiac Function and Recovery Improvement in Adult Accepting Cardiosurgery: A Randomized, Double-Blinded, Placebo-Controlled Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Rheumatic Heart Disease
  • Coronary Heart Disease
  • Drug: Glutamine
    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)
  • Drug: Ringer's solution
    Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h.
  • Experimental: Glutamine
    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).
    Intervention: Drug: Glutamine
  • Placebo Comparator: Ringer's solution
    Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation).
    Intervention: Drug: Ringer's solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Yuejiang Liu, Master +86-025-83262527 yuejiangliu@126.com
Contact: Liang Jing, PhD +86-025-83262522 jinglg@gmail.com
China
 
NCT01794884
glncardio001
No
Yuejiang Liu, Southeast University, China
Yuejiang Liu
Not Provided
Not Provided
Southeast University, China
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP