Evaluation of the effect of nutritional support provided by a nutritionist in improving the outcomes of patients admitted to the intensive care unit (ICU)

The main objective: Evaluation of the effect of nutritional support provided by nutritionist in improving the outcomes of patients hospitalized in the intensive care unit

The current study is a non-blinded randomized clinical trial with parallel groups that is conducted on 100 hospitalized patients.

Patients hospitalized in the intensive care unit of Firouzgar Hospital, Tehran, who are eligible to enter the study, will be randomly divided into intervention and control groups without blinding.

Inclusion criteria: Patients over 18 years of age hospitalized in surgical and general ICUs who are estimated to have a hospitalization period of more than 3 days are included in the plan. Exclusion criteria: GCS less than 8, C score for Child Pugh, pregnancy, Dialysis Failure to start nutritional support within the first 48 hours

Intervention group: There are patients who receive 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: There are patients who will receive nutritional support including enteral or intravenous nutrition from other medical services (surgeon, internist, etc.).

Length of stay in ICU, Duration of ventilator use or need, Occurring new pressure ulcers, The need for surgery or unplanned medical interventions, Occurrence of kidney disorders, Occurrence of liver disorders, Occurrence of infectious complications 48 hours after the start of the intervention, death

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.

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