The goal of this clinical trial is to determine the optimal protein administration strategy for enhancing both nutritional and clinical outcomes, as well as reducing complications and mortality in ICU patients at risk for refeeding syndrome (RS). This study will include critically ill patients at risk for RS who are receiving supportive nutrition. The primary hypothesis is that higher protein intake will lead to a decreased incidence of refeeding syndrome. It is also expected that patients receiving more protein will have better clinical outcomes, lower mortality, and shorter ICU and hospital stays.
Willingness to cooperate and complete the informed consent form by the patient or legal guardian;
age ≤ 18 years and < 65 years;
Non-pregnant and non-lactating;
Serum creatinine ≥ 1.1 mg/dl for women and ≥ 1.2 mg/dl for men;
Unwillingness to continue cooperation during study;
Discharge or death of the patient earlier than 5 days from the start of the intervention;
Occurrence of side effects during the study
Parallel
Whey protein
Dietary supplementWhey protein powder will be provided with nutritional support in both groups if needed to meet the target protein intake.
Number of participants with refeeding syndrome
Refeeding syndrome will be diagnosed based on a decrease in serum levels of electrolytes, including potassium, magnesium, and phosphate, within the first 5 days of nutrition delivery.
Incidence of infection
Determining and comparing the incidence of infection and its duration
Number of participants with organ failure as measured by SOFA score
Organ failure will be assessed using the SOFA Score (Sequential Organ Failure Assessment), which evaluates the function of the following organ systems: Cardiovascular Respiratory Renal Hepatic Coagulation Neurological
Duration of ICU stay
Duration of hospital stay
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Shahid Beheshti University
Lead sponsor
Shahid Beheshti University of Medical Sciences
Sponsor institution
