]>
IRCT20180619040151N4 IRCT 2019-11-07 Mashhad University of Medical Sciences Determination of the effect of high protein nutritional support in comparison to nutritional support with common protein in intensive care unit patients Evaluation of the effect of high protein nutritional support in comparison to nutritional support with regular protein intake in intensive care unit patients: a double-blind randomized clinical trial 2019-10-11 anticipated 60 Complete https://irct.ir/trial/40550 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting 60 patients based on inclusion criteria, they will be divided into two groups of intervention or control through stratified block randomization by using the numbered, sealed and stapled envelopes, Blinding description: In the present study, both patients and outcome assessors will be blinded throughout the study. 3 Critical ill patients. Intervention 1: The intervention group received 2.2 g/kg/day of Karen's Iso Whey protein via gavage feeding for 12 days. Surplus protein was primarily provided through enteral nutrition (BTF), with parenteral amino acids used only if enteral intake was insufficient. Intervention 2: Control group: 1 g / kg of Karen's Iso Whey protein per day by gavage feeding method in 12 days. (This amount of surplus protein will be given with BTF is given to patients.). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Abdolreza Norouzy
Azadi-squre
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3800 2382 norouzya@mums.ac.ir Mashhad University of Medical Sciences scientific Abdolreza Norouzy
Azadi-squre
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3800 2382 norouzya@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 18-80 years old Patients who have been ventilated for at least the first 72 hours of admission Completion of informed consent form in the first stage of legal guardianship in case of failure in this field to the judge. Ability to enteral feed in the first 24 to 48 hours of admission. Lack of participation in any other interventional research project. ICU admission 18 years 80 years Both Pregnant or lactation Patients require only parenteral nutrition History of diseases such as hepatocirrhosis and End-stage renal disease. inability to tolerate EN receipt of the study intervention for fewer than four days frequent need for blood transfusions; or physician discretion deeming the patient unsuitable for participation. Z00.01 Encounter for general adult medical examination with abnormal findings N/A Placebo The intervention group received 2.2 g/kg/day of Karen's Iso Whey protein via gavage feeding for 12 days. Surplus protein was primarily provided through enteral nutrition (BTF), with parenteral amino acids used only if enteral intake was insufficient. Control group: 1 g / kg of Karen's Iso Whey protein per day by gavage feeding method in 12 days. (This amount of surplus protein will be given with BTF is given to patients.) Mortality. Timepoint: mortality in the intensive care unit, days 28 and 60 after intaking protein. Method of measurement: If the patient is discharged from the intensive care unit, the patient will be contacted by telephone. Nutrition Risk in the Critically Ill (NUTRIC) Score. Timepoint: Before intervention. Method of measurement: Nutrition Risk in the Critically Ill (NUTRIC) Score. Acute Physiology and Chronic Health Evaluation (APACHE II) score changes. Timepoint: Before intervention. Method of measurement: Acute Physiology and Chronic Health Evaluation (APACHE II) score. Sequential Organ Failure Assessment (SOFA) score. Timepoint: Before intervention, day 3, 5, 7, 9 and 11. Method of measurement: Sequential Organ Failure Assessment (SOFA) Score. SARC-F Screen for Sarcopenia changes. Timepoint: Before intervention. Method of measurement: SARC-F Score. Clinical Frailty Scale changes. Timepoint: Before intervention. Method of measurement: Clinical Frailty Scale score. Mashhad University of Medical Sciences Approved 2018-12-11 Ethics committee of Mashhad university of Medical Sciences Mashhad University of Medical Sciences, Mashhad, Park Square. Mashhad Razavi Khorasan Iran (Islamic Republic of)