Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01794884

First Posted: February 20, 2013

Last Update Posted: May 28, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

Start Date ^ICMJE

January 2013

Primary Completion Date

March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Complete list of historical versions of study NCT01794884 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

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

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

Enrollment ^ICMJE

Completion Date

March 2014

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

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

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