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IRCT20170903036041N6 IRCT 2023-07-06 Iran University of Medical Sciences The effect of protein with different doses on nitrogen balance The effect of different doses of protein on nitrogen balance and clinical outcomes in intensive care unit patients 2023-07-08 anticipated 60 Complete https://irct.ir/trial/71032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method was used in this study. The size of the blocks is considered to be six and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A, B and C. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output, Blinding description: We will inform the supervisor after selecting each patient for the study and they are based on the randomized output of the randomization software and its matching to the patient's number the interventions will be sent in a form that is not known to the patients, prescriptive, and evaluator of the outcomes. Blinding process in this study is double blinded. Participants in the study will be blinded of interventions also the physicians will be blinded of the type of interventions received by the participants when they evaluated the outcome. 2-3 Patients admitted to the intensive care unit. Intervention 1: The first intervention group: protein with a dose of 2.6 grams per kilogram of body weight daily for seven days, produced by Karen Pharmaceutical Company. Intervention 2: The second intervention group: protein with a dose of 2 grams per kilogram of body weight daily for seven days, produced by Karen Pharmaceutical Company. Intervention 3: Control group: protein with a dose of 1.3 grams per kilogram of body weight daily for seven days, produced by Karen Pharmaceutical Company. 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 decision has been made yet.
public Rashin Taghizadeh
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9233 taghizadehrashin@gmail.com Iran University of Medical Sciences scientific Omid Moradimoghadam
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 moradimoghadam.o@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years At least 11 days of hospitalization in the intensive care unit 18 years no limit Both Death or discharge before 11 days of hospitalization in the intensive care unit Patients with liver, kidney and dialysis failure Anuric, oliguric or diarrhea patients Patients with high drain secretions A glomerular filtration rate less than 50 Z01.8 Encounter for other specified special examinations Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group: protein with a dose of 2.6 grams per kilogram of body weight daily for seven days, produced by Karen Pharmaceutical Company The second intervention group: protein with a dose of 2 grams per kilogram of body weight daily for seven days, produced by Karen Pharmaceutical Company Control group: protein with a dose of 1.3 grams per kilogram of body weight daily for seven days, produced by Karen Pharmaceutical Company Nitrogen balance. Timepoint: Urine 24 hours admission time, time to reach the protein target and the 11 day study. Method of measurement: Based on the measurement of urea concentration in urine. Thickness of biceps brachii muscle. Timepoint: Beginning and day 11 of the study. Method of measurement: Sonography. Duration of use of mechanical ventilation. Timepoint: Duration of hospitalization. Method of measurement: Visit the patient/patients' files. The duration of the patient's hospitalization in the intensive care unit. Timepoint: The total number of days the patient is in the ward. Method of measurement: Patients' files. The number of positive cultures of nosocomial infection. Timepoint: The duration of the patient's hospitalization in the intensive care unit. Method of measurement: The number of positive culture results. Mortality. Timepoint: 28 days after receiving interventions. Method of measurement: The discharge status of the patient as well as telephone follow-up 28 days after receiving the intervention. Iran University of Medical Sciences Approved 2023-06-03 Ethics committee of Iran university of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)