Protocol summary
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Study aim
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Evaluation of oral administration of glutamine to improve cardiovascular function in patients undergoing open heart surgery and to evaluate the effect of this combination on surgical outcomes.
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Design
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The randomized clinical trial with the intervention and control group, parallel groups, double blinded
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Settings and conduct
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A randomized clinical trial that is performed on patients undergoing non-emergency open heart surgery who are referred to Fatemeh Zahra Hospital in Sari. The population studied in this study includes all adult patients (aged 18-80) including men and women who have inclusion criteria for research. Patients and therapists are not aware of the type of drug contained in powders (glutamine, Avicel and starch), and only the researcher knows the code based on the code (code A or code B)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age over 18 years, Patients who are candidates for open heart surgery, Sinus rhythm in the patient before surgery
Exclusion criteria: Age over 80 years, History of chronic lung, liver, kidney and thyroid diseases and heart failure, Total Bilirubin more than 10 mg / dL, Creatinine clearance less than 30 ml / min
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Intervention groups
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A total of 106 patients with open heart surgery candidates were randomly divided into two groups of 53. For the first group, 0.5 g / kg of glutamine is taken orally once a day, and for the control group, placebo (Avicel and starch powder) is added. The drug forms of placebo are prepared in terms of the appearance of glutamine.
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Main outcome variables
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Duration of admission to ICU, Duration of hospitalization, Mortality after surgery
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151109024975N10
Registration date:
2018-08-29, 1397/06/07
Registration timing:
prospective
Last update:
2019-07-27, 1398/05/05
Update count:
1
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Registration date
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2018-08-29, 1397/06/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-21, 1397/06/30
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Expected recruitment end date
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2019-04-19, 1398/01/30
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Actual recruitment start date
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2018-09-21, 1397/06/30
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Actual recruitment end date
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2019-04-19, 1398/01/30
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Trial completion date
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2019-04-19, 1398/01/30
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Scientific title
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Evaluation of Oral Glutamine Administration on Reduction of Myocardial Dmage After Open Heart Surgery, a Prospective Randomized Clinical Trial Study
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Public title
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Effect of Glutamine on Reducing Myocardial Damage
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 18 years
Candidate for open heart surgery
Preoperative sinus rhythm
Normal function of liver, renal system, pulmonary system and thyroid
Exclusion criteria:
Emergency patients
Serious water and electrolyte disorders
Unwillingness to co-operate with the patient
History of chronic lung, liver, kidney and thyroid diseases and heart failure
Age over 80 years
Pregnant and lactating women
Patients who are hypersensitive to glutamine or who are banned in any way by their administration of glutamine
Total Bilirubin more than 10 mg / dL
Creatinine clearance less than 30 ml / min
Absolute Absence of Intestinal Feeding
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
106
Actual sample size reached:
106
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random method and description of each method: simple randomization
After determining the size of the sample, 106 people, 53 in the control group and 53 in the intervention group were considered. By co-ordinating medical records, this number was considered average for the duration of the appointment, and then the list of individuals was determined. The list was prepared based on the patients' turn-by-turn and then, using the random numbers table, the numbers of the control and intervention group were determined and compared to the coordination for the next steps.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In the informed consent form, patients are told that they may receive glutamine or placebo (Avicel powder and starch). Therefore, patients are not aware of their treatment group. Since patients and therapists are not aware of the type of drug contained in powders (glutamine, Avicel and starch), only the researcher is aware of the powder on the package code (code A or code B).
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-24, 1396/10/03
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Ethics committee reference number
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IR.mazums.REC.1396.3093
Health conditions studied
1
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Description of health condition studied
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Acute coronary syndrome
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ICD-10 code
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I24.0
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ICD-10 code description
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Acute coronary thrombosis not resulting in myocardial infarction
Primary outcomes
1
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Description
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Myocardial injury after open heart surgery
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Timepoint
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The day before the surgery (before the intervention) and the first and second days after surgery
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Method of measurement
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SOFA score
Secondary outcomes
1
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Description
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Duration of admission to ICU
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Timepoint
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Duration of admission
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Method of measurement
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Patients follow up
2
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Description
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Duration of hospitalization
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Timepoint
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Duration of admission
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Method of measurement
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Patients follow up
3
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Description
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Mortality
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Timepoint
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Duration of admission
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Method of measurement
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Patients follow up
Intervention groups
1
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Description
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Intervention group: A dose of 0.5 g / kg of glutamine powder is administered orally once a day during the ICU for patients.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in the control group received placebo (Avicel powder and starch). The frequency and duration of use of placebo in the control group were similar to oral administration of glutamine powder in the intervention group (once a day and up to the time of discharge from the ICU). Patients undergoing coronary artery bypass grafting, the drug is fed through the nasopharyngeal tube. The placebo is structurally similar to glutamate powder.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sari University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available