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IRCT20210920052530N1 IRCT 2022-06-21 Artesh University of Medical Sciences The effect of L-citrulline supplementation in ventilated intensive care unit patients The effect of L-citrulline supplementation in ventilated intensive care unit patients: A double-blind randomized controlled trial 2022-01-20 anticipated 30 Complete https://irct.ir/trial/63954 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: Subjects will be randomly assigned for each group via a computer-generated assignment sequence in a centralized, blinded fashion. The randomization sequence is programmed in advance and generated by a statistician independent of the study. Physicians will be assigned the treatment after randomization, which are accessible through dedicated web-based software. Investigators, patients, and research staff were masked to the randomization list, Blinding description: Except for the pharmacist who is in charge of preparing the supplements and the randomization sequence, Investigators, patients, and research staff were masked to the randomization list. This study is used to conceal the random allocation of coded cans. It will be hidden from participants and researchers until the end of the study. The degree of compliance of hospitalized people with the assigned intervention will be done by reviewing the drug card of the hospitalized ward. 3 Ventilated intensive care unit patients. Intervention 1: Intervention group: Patients in the citrulline group will receive 10 grams of L-citrulline powder daily for 7 days. Intervention 2: Control group: Patients in the placebo group will receive 10 grams of microcrystalline cellulose per day for 7 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Mohammad Reza Asgary
AJA university of medical sciences, Etemad zadeh street, Fatemi-Gharbi Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1416753955 +98 21 4382 2449 mohammadreza.askary1994@gmail.com Artesh University of Medical Sciences scientific Mohammad Reza Asgary
AJA university of medical sciences, Etemad zadeh street, Fatemi-Gharbi Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1416753955 +98 21 4382 2449 mohammadreza.askary1994@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Required invasive ventilation via an intubation or tracheotomy tube for at least 72 hours after study entry Expected to survive and remain in the ICU for at least 96 hours after its onset 18 years no limit Both The age of fewer than 18 years Pregnancy Previous allergy to citrulline or arginine A history of gastrointestinal disease, digestive tract surgery, intestinal obstruction, paralytic ileus, intestinal ischemia, septic patients, and hyperthyroidism J95.85 Complication of respirator [ventilator] Treatment - Drugs Treatment - Drugs Intervention group: Patients in the citrulline group will receive 10 grams of L-citrulline powder daily for 7 days. Control group: Patients in the placebo group will receive 10 grams of microcrystalline cellulose per day for 7 days. Ventilator dependence. Timepoint: Count the number of ventilator dependence days up to 28 days after supplementation. Method of measurement: Count the number of ventilator dependence days. Mortality Rate. Timepoint: Number of deaths due to a specific disease divided by the total number of patients up to 28 days after supplementation. Method of measurement: Number of deaths due to a specific disease divided by the total number of patients. Evaluate the severity of the disease. Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: Measurement of disease severity is calculated based on the parameters of blood pressure, blood gases and patient's consciousness. Evaluate the malfunction of multi-organ. Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: The Multi-Organ Dysfunction Questionnaire is calculated based on markers such as blood pressure, respiratory gases, respiratory support, bilirubin, platelets and creatinine, and the patient's urea. Clinical Pulmonary Infection Score (CPIS). Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: Using the CPIS questionnaire. Duration of hospitalization. Timepoint: The interval between the period of admission and the period of discharge from the hospital in terms of days. Method of measurement: The interval between the period of admission and the period of discharge from the hospital in terms of days. Blood indicators. Timepoint: Before the intervention and 7 days after starting the supplement. Method of measurement: CRP is measured by the method of agglutination of latex particles on the slide (ENISON Co kits). Albumin is assessed with a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Abcam). Blood urea nitrogen (BUN) is determined using enzymatic methods. Alanine transaminase (ALT), aspartate transaminase (AST), and lactate dehydrogenase (LDH) are measured based on the method recommended by the IFCC (International Federation of Clinical Chemistry). Artesh University of Medical Sciences Approved 2022-01-12 Research Ethics Committees of AJA University of Medical Sciences AJA university of medical sciences, Etemad zadeh street, Fatemi-Gharbi Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)