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IRCT20200405046951N2 IRCT 2023-01-28 Iran University of Medical Sciences Investigating the effect of nutritional support on the recovery of patients admitted to the intensive care unit Evaluation of the effect of nutritional support provided by a nutritionist in improving the outcomes of patients admitted to the intensive care unit (ICU) 2022-12-22 anticipated 100 Complete https://irct.ir/trial/66980 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the limited randomization method of the block randomization type. The randomization tool is also used from random sequence generation software (https://www.graphpad.com/quickcalcs/), which, in addition to simple randomization, is capable of generating random sequence by block method (10 blocks of 10). For concealment, we use random allocation concealment, which refers to the method used to perform a random sequence on study participants, in such a way that the allocated group is not known before individual allocation. By using sealed opaque letter envelopes with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. N/A Critically ill patient. Intervention 1: Intervention group: Patients admitted to the intensive care unit are under nutritional support including enteral or intravenous nutrition by a nutritionist. Enteral feeding will be done with gavage powders from Karen company, parentral feeding will be done with intralipid and amino acid solutions from Fresenius Kaby, and the amount to be consumed will be determined based on the patient's weight and other conditions. Intervention 2: Control group: patients hospitalized in the intensive care unit who will receive nutritional support including enteral or intravenous nutrition from other medical services (surgeon, internist, etc.). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Azadeh Mottaghi
No.10, Firoozeh alley, Vali Asr Ave.
Tehran Iran (Islamic Republic of) 15937 0098218608060 mottaghi.azadeh@gmail.com Iran University of Medical Sciences scientific Dr. Aazdeh Mottaghi
No.10, Firoozeh Alley. Vali Asr Ave.
Tehran Iran (Islamic Republic of) 1593716615 +98 21 86701 mottaghi.azadeh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Hospitalization period of more than 3 days in the intensive care unit 18 years no limit Both Patients with extensive head trauma (GCS less than 8) Severe liver disease (score C for Child Pugh) Treated with dialysis Patients who are admitted to the ICU for open-heart surgery are not included in the study because the duration of their hospitalization depends on several underlying factors. Pregnancy Patients who have not received nutritional support 48 hours after being admitted to the ICU for some reason will not be included in the plan Treatment - Other Treatment - Other Intervention group: Patients admitted to the intensive care unit are under nutritional support including enteral or intravenous nutrition by a nutritionist. Enteral feeding will be done with gavage powders from Karen company, parentral feeding will be done with intralipid and amino acid solutions from Fresenius Kaby, and the amount to be consumed will be determined based on the patient's weight and other conditions. Control group: patients hospitalized in the intensive care unit who will receive nutritional support including enteral or intravenous nutrition from other medical services (surgeon, internist, etc.). Length of stay in ICU. Timepoint: before the intervention and when the patient is discharged from the intensive care unit. Method of measurement: Counting days of hospitalization. Duration of ventilator use or need. Timepoint: During the intervention period (the duration of the patient's hospitalization in the intensive care unit). Method of measurement: Counting days of intervention (Event Registration Questionnaire). Mortality rate. Timepoint: During the intervention period (the duration of the patient's hospitalization in the intensive care unit). Method of measurement: Event registration (Event Registration Questionnaire). Occurring new pressure ulcers. Timepoint: During the intervention period (the duration of the patient's hospitalization in the intensive care unit). Method of measurement: Event registration (Event Registration Questionnaire). The need for surgery or unplanned medical interventions. Timepoint: During the intervention period (the duration of the patient's hospitalization in the intensive care unit). Method of measurement: Event registration (Event Registration Questionnaire). Occurrence of kidney disorders with the definition of creatinine more than 1.2 mg/dL or the need for dialysis. Timepoint: During the intervention period (the duration of the patient's hospitalization in the intensive care unit). Method of measurement: Event registration (Event Registration Questionnaire). The occurrence of liver disorders with the definition of bilirubin more than 1.2 mg/dL. Timepoint: During the intervention period (the duration of the patient's hospitalization in the intensive care unit). Method of measurement: Event registration (Event Registration Questionnaire). Incidence of infectious complications according to the definition of infection in the ICU of the International Sepsis Association (ventilator-associated pneumonia, bacteremia, urinary tract infections, wound infections, abdominal infections) 48 hours after the start of the intervention. Timepoint: During the intervention period (the duration of the patient's hospitalization in the intensive care unit). Method of measurement: Event registration (Event Registration Questionnaire). Iran University of Medical Sciences Approved 2022-08-09 Research Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat highway Tehran Tehran Iran (Islamic Republic of)