An interventional study of Whey protein in Critical Illness, Malnutrition and Refeeding Syndrome, sponsored by Shahid Beheshti University. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Shahid Beheshti University · Not applicable, Interventional, and Supportive care
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.
Patients will be randomly assigned to two groups: the high-protein group and the standard-protein group. Upon ICU admission, and after meeting the inclusion criteria and identifying a risk of refeeding syndrome (RS), they will be allocated to one of the two groups. Patient selection for RS risk will be based on the diagnostic criteria outlined in the 2020 ASPEN guidelines. The m-NUTRIC and APACHE II scores will be calculated for all patients at ICU admission and 24 hours before the initiation of feeding. Monitoring for multi-organ dysfunction syndrome (MODS) will involve daily laboratory tests and organ failure assessment using the SOFA score.
Before starting the nutritional intervention, all patients will receive 100 mg of thiamine daily for one week, along with a daily multivitamin-mineral supplement. Due to the risk of RS, calorie intake will begin at low levels and will be cautiously increased in both groups. To calculate the energy needs, ideal body weight will be used. In the high-protein group, the target protein intake will be 2 grams per kilogram of body weight per day, while in the standard-protein group, it will be 1.3 grams per kilogram of body weight per day. Protein will be introduced gradually, starting from a low level, as part of nutritional support, with whey protein powder added if needed as a supplement. If serum creatinine levels rise, protein powder will be removed from the patient's diet. The intervention duration will be 14 days, with a minimum of 5 days.
The primary clinical outcome is the incidence of refeeding syndrome (RS), while secondary outcomes include the occurrence of infections, hospital length of stay, ICU length of stay, multi-organ failure, and mortality within 45 days of admission. RS will be diagnosed according to the 2020 ASPEN guidelines. Serum concentrations of potassium, magnesium, phosphate, glucose, urea, and creatinine will be measured daily for one week.
24 studies on the registry are indexed under Refeeding Syndrome; 7 are open to participants now.
Browse Refeeding Syndrome studies →Shahid Beheshti University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Compared within Refeeding Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Metastases
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The target protein intake of 2 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement.
Dietary Supplement: Whey protein
The target protein intake of 1.3 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement.
Dietary Supplement: Whey protein
Whey 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.
Time frame: within the first 5-7 days of nutrition delivery
Incidence of infection
Determining and comparing the incidence of infection and its duration
Time frame: Within 5-14 days of nutrition delivery
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
Time frame: Within 5-14 days of nutrition delivery
Duration of ICU stay
Time frame: up to 7 weeks after admission
Duration of hospital stay
Time frame: up to 7 weeks after admission
Mortality
45-day mortality from the time of ICU admission
Time frame: up to 45-day
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Feb 2026, 12 months after the start.
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Studies of the drug tested here: Whey Proteins
Shahid Beheshti University