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NCT Number: NCT01794884

Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery

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.

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Key information

Conditions

Rheumatic Heart Disease Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Coronary Disease Coronary Heart Disease Gram-Positive Bacterial Infections Heart Diseases Infections Myocardial Ischemia Rheumatic Fever Streptococcal Infections Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glutamine

Drug

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 names: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)

Ringer's Solution

Drug

Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Troponin I(cTnI)

    Time frame: postanescesia before surgery, 6, 20 hours after CPB

    CTnI is a sensitive indicator of myocardial damage.

  2. Brain Natriuretic Peptide (BNP)

    Time frame: postanescesia before surgery, 6, 20 hours after CPB

    BNP is a sensitive indicator of cardiac dysfunction.

  3. 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.

  4. 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.

  5. Heart issue O-GlcNAc

    Time frame: 20 minutes after CPB

    The same mass of heart tissue described above will be used for the measurements.

  6. 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.

Sponsors and collaborators

Lead sponsor

Yuejiang Liu

Other

Registry information

Official study title

Intravenous Supplementation of Glutamine Preoperatively for Cardiac Function and Recovery Improvement in Adult Accepting Cardiosurgery: A Randomized, Double-Blinded, Placebo-Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2013
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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