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IRCT20220508054780N2 IRCT 2023-04-26 Mashhad University of Medical Sciences The effectiveness of citrulline supplementation on tolerance and complications of nutritional in patients admitted to the intensive care unit A clinical trial to compare the effectiveness of citrulline supplementation with placebo on tolerance and complications of nutritional in patients admitted to the intensive care unit 2023-05-22 anticipated 60 Complete https://irct.ir/trial/69752 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be simple randomly assigned to two groups using a random table type and opaque envelopes will be used for concealment, Blinding description: The participants and responsible for data collection are blind to group allocation and the type of intervention. 1-2 Tolerance and complications of nutritional in patients admitted to the intensive care unit. Intervention 1: Intervention group: The intervention group will receive 3 mg citrulline supplementation (Daghigh Tajhiz Ario, Tehran, Iran) per day for 14 days. Intervention 2: Control group: The control group will receive placebo (There is no citrulline in it, but it has the same color, taste, structure and shape as citrulline, produced by the research center of faculty of pharmacy, Mashhad University of Medical Sciences) per day for 14 days. Yes - There is a plan to make this available What will be shared: The research data obtained from the main outcomes of the study can be shared freely as 'open data'. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Benyamin Fazli provides the data analysis to the applicants via email: fazlib@mums.ac.ir. How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Benyamin Fazli
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2711 fazlib@mums.ac.ir Mashhad University of Medical Sciences scientific Benyamin Fazli
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2711 fazlib@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Aged between 18 and 75 years Non-participation in any other intervention research design 18 years 75 years Both Having citrulline allergies Pregnant women The patient dies in the first 4 days of admission Patient who require of only parenteral nutrition Y57.8 Other drugs and medicaments Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive 3 mg citrulline supplementation (Daghigh Tajhiz Ario, Tehran, Iran) per day for 14 days. Control group: The control group will receive placebo (There is no citrulline in it, but it has the same color, taste, structure and shape as citrulline, produced by the research center of faculty of pharmacy, Mashhad University of Medical Sciences) per day for 14 days. Nutritional status. Timepoint: Before, 2, 7 and 14 days after intervention. Method of measurement: Using by NUTRIC score questionnaire. Gastrointestinal bleeding. Timepoint: Before, 2, 7 and 14 days after intervention. Method of measurement: Using by the sequential organ failure assessment (SOFA) score. Duration of hospital and intensive care unit stay. Timepoint: From the time of admission to the end of the intervention. Method of measurement: Based on the number of days the patient was hospitalized. Duration of mechanical ventilation. Timepoint: From the time of admission to the end of the intervention. Method of measurement: The rate of using of patient the ventilator. 28-day mortality rate. Timepoint: 28 days after intervention. Method of measurement: Based on days after intervention. Mashhad University of Medical Sciences Approved 2023-01-09 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)