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Oral Glutamine in Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT02491931
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social

Brief Summary:
Introduction: Glutamine (GLN) is the most abundant free amino acid in the body. It modulates immune cell function and is an important energy substrate for most cells (especially for enterocytes and lymphocytes) in critical patients. GLN levels significantly decreased during sepsis/critical illness leading to an increase in infectious complications, organ failure and mortality. Moreover, in cases of ischemia/reperfusion injury in the myocardium, GLN increases the levels of Adenosine triphosphate (ATP)/Adenosine diphosphate (ADP) ratio and prevents intracellular lactate accumulation. Recently, the perioperative effect of intravenous and oral GLN treatment been associated in lowering levels of cardiac injury markers such as Troponin-I (TROP-I) and the number of postoperative complications in patients who underwent Cardiopulmonary Bypass (CPB). The aim of the study was to analyze the oral dose of preoperative oral GLN treatment in patients who underwent CPB with extracorporeal circulation in Mexican patients.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Dietary Supplement: Supplement/placebo intake Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Oral Glutamine Reduces Myocardial Damage After Coronary Revascularization Under Cardiopulmonary Bypass
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Active Comparator: GLN group
All patients in the GLN group received an oral GLN supplement. The total GLN dose given to patients was standardized to 0.5 g/kg/day during 3 days prior to CPB, and one final dose of 0.25 g/kg/day of GLN/maltodextrin in the morning of surgery 4 hours prior to initiation of anesthesia.
Dietary Supplement: Supplement/placebo intake
Patients will receive either GLN or placebo prior to cardiovascular surgery under extracorporeal circulation, during 3 days and one final dose 4 hours prior to anesthesia.

Placebo Comparator: CONT group
All patients in the GLN group received an oral maltodextrin supplement, similar in shape and texture as GLN supplement. The total placebo given to patients was standardized to 0.5 g/kg/day during 3 days prior to CPB, and one final dose of 0.25 g/kg/day of maltodextrin in the morning of surgery 4 hours prior to initiation of anesthesia.
Dietary Supplement: Supplement/placebo intake
Patients will receive either GLN or placebo prior to cardiovascular surgery under extracorporeal circulation, during 3 days and one final dose 4 hours prior to anesthesia.




Primary Outcome Measures :
  1. Troponin-I [ Time Frame: 1 hour before surgery. ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  2. Creatine Kinase [ Time Frame: 1 hour before surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  3. Creatine Kinase - Mb [ Time Frame: 1 hour before surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase-Mb levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  4. Troponin-I [ Time Frame: one hour after surgery. ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  5. Creatine Kinase [ Time Frame: one hour after surgery. ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase-Mb levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  6. Creatine Kinase - Mb [ Time Frame: one hour after surgery. ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase-Mb levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  7. Troponin-I [ Time Frame: 12 hours after surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  8. Creatine Kinase [ Time Frame: 12 hours after surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  9. Creatine Kinase - Mb [ Time Frame: 12 hours after surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  10. Troponin-I [ Time Frame: 24 hours after surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  11. Creatine Kinase [ Time Frame: 24 hours after surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  12. Creatine Kinase - Mb [ Time Frame: 24 hours after surgery ]
    Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).


Secondary Outcome Measures :
  1. Postoperative Stroke [ Time Frame: 15 days after surgery. ]
    Any stroke occurred in patients durin UCI stay was counted as 1 per event, measured in frequency of occurrence.

  2. Length of stay in UCI. [ Time Frame: 15 days after surgery. ]
    The total time of stay in UCI was measured in days in both groups.

  3. Mortality [ Time Frame: 15 days after surgery. ]
    All deceases were captured in both groups during UCI stay until discharge of the patient.

  4. Postoperative Infections [ Time Frame: 15 days after surgery. ]
    Any infections occurred in patients durin UCI stay was counted as 1 per event, measured in frequency of occurrence.

  5. Postoperative vasopressor therapy [ Time Frame: 15 days after surgery. ]
    When any vasopressor was needed during UCI stay, was counted as 1 per event, measured in frequency of occurrence.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a confirmed diagnosis of Ischemic heart disease in whom cardiac revascularization (cardiac by pass) was going to be performed.
  • Written informed consent from each patient.

Exclusion Criteria:

  • Preexisting kidney disease
  • Liver dysfunction

    .Drug or alcohol abuse Positivity to human immunodeficiency virus (HIV)

  • Hepatitis B / C
  • Allergies against components of GLN.
  • Patients with an ongoing ischemia, defined by persistent elevation of TROP-I and CPK-MB levels.
  • If any dietetic supplement of GLN was taken simultaneously.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491931


Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Study Director: González-Ojeda Alejandro, MD. PhD. F.A.C.S. Instituto Mexicano del Seguro Social
Principal Investigator: Chávez-Tostado Mariana, M.Sc. R. Nutr. Instituto Mexicano del Seguro Social

Publications of Results:

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Responsible Party: Alejandro Gonzalez-Ojeda, MD., Ph.D., F.A.C.S., Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02491931     History of Changes
Other Study ID Numbers: Glutamine-2015
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Keywords provided by Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social:
Cardiac Surgical Procedures
Cardiovascular Surgical Procedures
Dietary Supplements
Glutamine
TROPONIN I
cardiopulmonary bypass
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases