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IRCT20120703010178N14 IRCT 2018-04-11 Shahid Beheshti University of Medical Sciences Effect of high protein regime in nurocritical patients Comparison of the Effectiveness of High-protein Nutritional regimes with Normal regimes on Neuronal Bio-markers and Clinical Outcome of Neurocritical Patients 2018-04-04 anticipated 30 Complete https://irct.ir/trial/29922 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning each regimen to patients is randomized and random blocked blocks with block size 6 (using a permuted block randomization table). 3 Diseases of the nervous system injury. Intervention 1: Intervention group: Prescribing protein (1.5-2 mg/kg/day) for 5 days. Intervention 2: Control group: Prescribing a regular diet in the intensive care unit for 5 days. 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 Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 0087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 218820087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients older than 16 years old who have one of the following factors and stay in ICU for 5 days. Subarachnoid Hemorrhage Subdural Hematoma Traumatic brain injury Aneurysm Intracranial hemorrhage Others 16 years no limit Both Patient's death during the first three days of study Patient dis-admit with personal satisfaction within the first three days Disapprove of the patient to enter the research Contraindication of receiving high protein die Hepatic encephalopathy An allergy to the drug Consumer of Warfarin Pregnancy Metabolic disorders (gout, phenylketonuria) Chronic renal failure Proteinuria is higher than 3 grams per day S06.2 Diffuse traumatic brain injury Treatment - Other N/A Intervention group: Prescribing protein (1.5-2 mg/kg/day) for 5 days Control group: Prescribing a regular diet in the intensive care unit for 5 days Neuron Specific Enolase. Timepoint: At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention. Method of measurement: Enolase CanAg kit. Serum Transtreatin Level. Timepoint: At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention. Method of measurement: Prealbumin Minineph *25T. Nitrogen Balance. Timepoint: At the beginning of the intervention (before the intervention) and 5 days after the beginning of the intervention. Method of measurement: Based on urea concentration. Extended Glasgow Outcome Scale. Timepoint: The end of the first, second and third months after the begining intervention. Method of measurement: Score of Extended Glasgow Outcome Scale. Mortality. Timepoint: The end of the first, second and third months after the begining intervention. Method of measurement: Will be checked by phone. Effect of medication on neuron specific Enolase. Timepoint: At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention. Method of measurement: Blood sample. Effect of medication on serum prealbumin level. Timepoint: At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention. Method of measurement: blood sample. Effect of medication on nitrogen balance. Timepoint: At the beginning of the intervention (before the intervention) and 5 days after the beginning of the intervention. Method of measurement: Urine sample. Shahid Beheshti University of Medical Sciences Approved 2017-12-30 Ethics committee of Shahid Beheshti University of Medical Sciences Velenjak Street, Shahid Chamran High Way Tehran Tehran Iran (Islamic Republic of)