Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Comparing the Effects of High-protein Nutritional Support with Standard Protein Nutritional Support Through the Administration of Whey Protein Supplements on Clinical Outcomes of Critically Ill Patients At Risk for Refeeding Syndrome: a Randomized Comparative Clinical Trial
Shahid Beheshti University
150 participants
Feb 13, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- 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;
- No organ failure at the time of study enrollment;
- Intervention initiation within 48 hours of ICU admission;
- No history of metastatic cancer or end-stage disease;
- No absolute contraindications to enteral nutrition (e.g., persistent ileus, gastrointestinal ischemia, persistent or biliary vomiting, mechanical obstruction);
- No active infections, sepsis, severe sepsis, or septic shock;
- No intolerance to the whey protein supplement used in the current study;
- Not participating in other clinical trials concurrently with this study;
- No clinical conditions with higher or lower protein needs, such as burns, sepsis, cirrhosis, or chronic kidney disease;
- No diabetes with severe complications such as ketoacidosis, hyperosmolar coma, or acidosis.
Exclusion Criteria3
- 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
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Interventions
Whey protein powder will be provided with nutritional support in both groups if needed to meet the target protein intake.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06825377