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IRCT20120731010453N4 IRCT 2023-06-29 Shiraz University of Medical Sciences The effect of taurine in reducing the incidence of ventilator-associated pneumonia Evaluating the effectiveness of taurine in reducing the incidence of ventilator-associated pneumonia inchildren undergoing mechanical ventilation in the pediatric intensive care unit of Shiraz Namazi Hospital arandomized, double-blind clinical trial 2023-07-01 anticipated 72 Complete https://irct.ir/trial/70885 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: All patients are randomly divided into two groups receiving taurine supplements or placebo by permutation blocking method. Quadruple permutation block randomization: All possible blocks are arranged as follows: Block 1: Block ABAB 2: Block AABB 3: Block ABBA 4: Block BBAA 5: Block BABA 6: BAAB We need 18 blocks to select 72 people. We choose these blocks randomly from numbers 1 to 6. For example, if number 6 is chosen as the first block and number 2 is chosen as the second block, the people entering the study will be given BAABAABB in that order. Finally, group A receives placebo and group B receives taurine, Blinding description: In our study, the participants (patients) and the researcher do not know whether each patient received taurine or placebo. Taurine and placebo are both prepared in the form of 250 mg capsules with the same shape, color, and size and in the same packaging. Only one of the colleagues, who does not have a role in evaluating the results and analyzing the data, knows about the division of patients based on the table of random numbers. 3 Ventilator-associated pneumonia. Intervention 1: Intervention group: Patients receive taurine in the amount of 30 mg/kg in the form of 250 mg capsules (in two divided doses) (from Allmax Nutrition Company) until they are hospitalized in the intensive care unit. Intervention 2: Control group: Patients receive 30 mg/kg carboxymethyl cellulose in the form of 250 mg capsules (in two divided doses) (from Merck Company) until they are hospitalized in the intensive care unit. 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 There is no further information.
public Nasrin Shirzad yazdi
Abiverdi Ave, chamran Blvd
shiraz Iran (Islamic Republic of) 7194733681 +98 71 3627 0861 ny.shirzad@yahoo.com Shiraz University of Medical Sciences scientific Nasrin Shirzad yazdi
Faculty of Pharmacy, Shiraz, Rokn Abad, Karabehan St
shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4127 ny.shirzad@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study and complete the ethical consent form by the parents. All children aged 3 months to 15 years who need mechanical ventilation for more than 48 hours. 3 months 15 years Both Malignancy, AIDS Patients with heart failure Age less than three months Cystic fibrosis patients J95.851 Ventilator associated pneumonia Treatment - Drugs Placebo Intervention group: Patients receive taurine in the amount of 30 mg/kg in the form of 250 mg capsules (in two divided doses) (from Allmax Nutrition Company) until they are hospitalized in the intensive care unit. Control group: Patients receive 30 mg/kg carboxymethyl cellulose in the form of 250 mg capsules (in two divided doses) (from Merck Company) until they are hospitalized in the intensive care unit. The incidence of ventilator-associated pneumonia. Timepoint: During the intubation period of the patient in the intensive care unit. Method of measurement: Based on the criteria of ventilator-associated pneumonia (doctor's clinical suspicion, patient's tests, patient's radiograph, and culture results). The incidence of septic shock. Timepoint: As long as the patient is in the intensive care unit. Method of measurement: Diagnosis and confirmation by the doctor. Shiraz University of Medical Sciences Approved 2023-06-24 Ethics Committee of Shiraz University of Medical Sciences Shiraz, Zand Ave, Central building of Shiraz University of medical sciences. Shiraz Fars Iran (Islamic Republic of)