The effect of different doses of protein on nitrogen balance and clinical outcomes in intensive care unit patients

The effect of different doses of protein on nitrogen balance and clinical outcomes in intensive care unit patients

The design of this study is a parallel clinical trial in phase 2-3. It has a control group where patients will be assigned to study groups by block randomization method. Blinding is double-blind and the sample size is 60 patients.

The aim of this study is the effect of different doses of protein with 2.6, 2, and 1.3 g/kg on nitrogen balance and clinical outcomes of patients admitted to the intensive care unit of Rasoul Akram Hospital affiliated to Iran University of Medical Sciences. Both the patients and the evaluators of thickness of muscle will be blinding of the amount of dose received by the participants in the study groups, finally the type of blinding is double blinded.

Age over 18 years and at least 11 days of hospitalization in the intensive care unit are the included criteria. Non-Include criteria are Liver or kidney failure, dialysis, anuric, oliguric, or having diarrhea.

In this study, we will have three groups of patients giving different doses of protein.Patients giving doses of 2.6 and 2 g/kg will be intervention groups and patients giving dose of 1.3 g/kg will be control groups.

Nitrogen balance; thickness of biceps brachii muscle; duration of use of mechanical ventilation; the duration of the patient's hospitalization in the intensive care unit; the number of positive cultures of nosocomial infection; mortality.

The block randomization method was used in this study. The size of the blocks is considered to be six and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A, B and C. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output.

We will inform the supervisor after selecting each patient for the study and they are based on the randomized output of the randomization software and its matching to the patient's number the interventions will be sent in a form that is not known to the patients, prescriptive, and evaluator of the outcomes. Blinding process in this study is double blinded. Participants in the study will be blinded of interventions also the physicians will be blinded of the type of interventions received by the participants when they evaluated the outcome.

Finding of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.

Availability six months after the end of study.

Critical care fellowships, anesthesiologists, internists.

Requests may be made by organizations, journals or project supervisors. These requests will be read by the research team under the supervision of a university representative, and if the requests are reasonable, relevant de-identified data will be sent. This request may be some results of biomarkers or codes performed for data analysis.

The initial request can be sent to the email of the people who are in the scientific and general response section of the trial (taghizadehrashin@gmail.com, moradimoghadam.o@iums.ac.ir). Applicants can also refer to the Research Vice-Chancellor of Iran University of Medical Sciences located on Hemet Highway or the Iran Clinical Trial Center located in the Central Library of Iran University of Medical Sciences.

After the institution agrees to send data for requests, depending on whether the requester is inside the country or abroad, and also according to the type of requested data, the time to respond to the requests will be different. Finally, no request will take more than one month.