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Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01794884
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Yuejiang Liu, Southeast University, China

Tracking Information
First Submitted Date  ICMJE February 4, 2013
First Posted Date  ICMJE February 20, 2013
Last Update Posted Date May 28, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2013)
perioperative changes of Cardiac Index (CI) [ Time Frame: postanescesia before surgery, 2, 20 hours after cardiopulmonary bypass (CPB) ]
For each patient,a Swan-Ganz catheter will be inserted after anesthesia induction.CI and other values of hemodynamics will be measured.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
  • Troponin I(cTnI) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ]
    CTnI is a sensitive indicator of myocardial damage.
  • Brain Natriuretic Peptide (BNP) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ]
    BNP is a sensitive indicator of cardiac dysfunction.
  • Systemic inflammation [ Time Frame: postanescesia before surgery, 2, 20 hours after CPB ]
    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 ]
    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 ]
    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) ]
    Recovery index include duration of mechanical ventilation、duration of ICU stay、duration of hospital stay、adverse event and mortality.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2013)
  • Troponin I(cTnI) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ]
    CTnI is a sensitive indicator of myocardial damage.
  • Brain Natriuretic Peptide (BNP) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ]
    BNP is a sensitive indicator of cardiac dysfunction.
  • Systemic inflammation [ Time Frame: postanescesia before surgery, 2, 20 hours after CPB ]
    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 ]
    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 ]
    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 ]
    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) ]
    Recovery index include duration of mechanical ventilation、duration of ICU stay、duration of hospital stay、adverse event and mortality.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery
Official Title  ICMJE Intravenous Supplementation of Glutamine Preoperatively for Cardiac Function and Recovery Improvement in Adult Accepting Cardiosurgery: A Randomized, Double-Blinded, Placebo-Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatic Heart Disease
  • Coronary Heart Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2013)
60
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01794884
Other Study ID Numbers  ICMJE glncardio001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuejiang Liu, Southeast University, China
Study Sponsor  ICMJE Yuejiang Liu
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Southeast University, China
Verification Date May 2014

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