Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * 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,