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IRCT20151109024975N10 IRCT 2018-08-29 Mazandaran University of Medical Sciences Effect of Glutamine on Reducing Myocardial Damage Evaluation of Oral Glutamine Administration on Reduction of Myocardial Dmage After Open Heart Surgery, a Prospective Randomized Clinical Trial Study 2018-09-21 anticipated 106 Complete https://irct.ir/trial/31727 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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). 3 Acute coronary syndrome. Intervention 1: Intervention group: A dose of 0.5 g / kg of glutamine powder is administered orally once a day during the ICU for patients. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Gohar Eslami
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3354 3695 g.eslami@mazums.ac.ir Mazandaran University of Medical Sciences scientific Gohar Eslami
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3354 3695 g.eslami@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Candidate for open heart surgery Preoperative sinus rhythm Normal function of liver, renal system, pulmonary system and thyroid 18 years 80 years Both 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 I24.0 Acute coronary thrombosis not resulting in myocardial infarction Treatment - Drugs Placebo Intervention group: A dose of 0.5 g / kg of glutamine powder is administered orally once a day during the ICU for patients. 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. Myocardial injury after open heart surgery. Timepoint: The day before the surgery (before the intervention) and the first and second days after surgery. Method of measurement: SOFA score. Duration of admission to ICU. Timepoint: Duration of admission. Method of measurement: Patients follow up. Duration of hospitalization. Timepoint: Duration of admission. Method of measurement: Patients follow up. Mortality. Timepoint: Duration of admission. Method of measurement: Patients follow up. Mazandaran University of Medical Sciences Approved 2017-12-24 •Ethics committee of Mazandaran University of Medical Sciences Artesh Blvd., Fatemeh-zahra hospital Mazandaran University of Medical Scienses Sari Mazandaran Iran (Islamic Republic of)