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IRCT20120913010826N31 IRCT 2020-10-13 Yazd University of Medical Sciences Effect of beta-hydroxy beta-methylbutyrate, arginine and glutamine on complication after cardiac surgery Effect of Beta-hydroxy beta-methylbutyrate, Arginine and Glutamine supplementation in patients undergoing cardiac surgery on postoperative outcomes 2020-07-26 anticipated 80 Complete https://irct.ir/trial/50436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to the intervention or placebo, using a computer-generated sequence allocation with permuted blocks, in blocks of 2 with 1:1 allocation ratio to each group . Allocation concealment was via sealed opaque envelopes, Blinding description: Study supplements were identical in appearance . Investigators, patients, and clinicians will be blinded to treatment assignment. N/A cardiac surgery patients. Intervention 1: Intervention group: Intervention group will receive supplement which contains 7 grams of glutamine, 7 grams of arginine and 1.5 grams of hydroxy methylbutyrate. These supplements are given to patients twice a day for 1 month. Patients are given complete training before taking the supplement that mix sachets with 120 cc of cold water and consume. Intervention 2: Control group:Patients in the control group are given sachets containing maltodextrin, which are very similar to Hilagen supplements. These people are also told to consume 2 sachets daily with 120 cc of cold water. Yes - There is a plan to make this available What will be shared: Information about the main outcomes and variables will be shared and personal information is confidential When: Access starts about 3 months after the results are published. To whom: Students and graduates of this field Conditions: For use in similar research work Where to obtain: Dr Azadeh Najarzadeh: azadehnajarzadeh@gmail.com Mona Norouzi : mona.noruzi@yahooo.com How to obtain: The file and data will be sent to you two weeks after the review. Comments:
public Dr Azadeh Nadjarzadeh
Shahid Sadoughi
Yazd Iran (Islamic Republic of) 2010102748 003538209131 azadehnajarzadeh@gamil.com Yazd University of Medical Sciences scientific Azadeh Nadjarzadeh
Shahid sadoughi
Yazd Iran (Islamic Republic of) 20101012748 003538209131 azadehnajarzadeh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate and complete the informed consent form by the patient Age 18 to 70 years Body mass index (BMI) above 18.5 and below 30 Do not take supplements or formulas to strengthen the immune system before starting the study No infection and sepsis No need for other entral formulas due to special problems (kidney, lung, liver, etc) Candidate patients for heart surgery 18 years 70 years Both Drugs that affect metabolism such as steroids and male and female hormonal drugs or corticosteroids Abnormal liver function Metastatic cancer and autoimmune diseases Patients with thyroid, pituitary and hypothalamus dysfunction Treatment - Drugs Placebo Intervention group: Intervention group will receive supplement which contains 7 grams of glutamine, 7 grams of arginine and 1.5 grams of hydroxy methylbutyrate. These supplements are given to patients twice a day for 1 month. Patients are given complete training before taking the supplement that mix sachets with 120 cc of cold water and consume. Control group:Patients in the control group are given sachets containing maltodextrin, which are very similar to Hilagen supplements. These people are also told to consume 2 sachets daily with 120 cc of cold water. Biochemical evaluation of interleukin 1 (mean serum interleukin-1 concentration) Biochemical evaluation of interleukin 6 (mean serum interleukin-1 concentration) Biochemical evaluation of TNF-alpha (mean serum TNF-alpha concentration). Timepoint: Before and after of surgery. Method of measurement: Biochemical experiments. Duration of hospitalization in ICU and hospital. Timepoint: After cardiac surgery. Method of measurement: Check the patient file. Yazd University of Medical Sciences Approved 2019-12-31 ٍEthics committee of shahid sadoughi medical science university Shahid sadoughi, Yazd Yazd Yazd Iran (Islamic Republic of)