Actively Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Led by Shahid Beheshti University · Updated on 2025-02-14
150
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to cooperate and complete the informed consent form by the patient or legal guardian
- Age 18 years or older and under 65 years
- Not pregnant or breastfeeding
- Serum creatinine of at least 1.1 mg/dl for women and 1.2 mg/dl for men
- No organ failure when joining the study
- Nutrition intervention started within 48 hours of ICU admission
- No history of metastatic cancer or end-stage disease
- No absolute contraindications to enteral nutrition such as persistent ileus, gastrointestinal ischemia, persistent or biliary vomiting, or mechanical obstruction
- No active infections, sepsis, severe sepsis, or septic shock
- No intolerance to the whey protein supplement used in this study
- Not participating in other clinical trials at the same time
- No medical conditions requiring higher or lower protein needs like burns, sepsis, cirrhosis, or chronic kidney disease
- No diabetes with severe complications such as ketoacidosis, hyperosmolar coma, or acidosis
You will not qualify if you...
- Unwillingness to continue cooperation during the study
- Discharge or death within less than 5 days from the start of the intervention
- Development of side effects during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences
Tehran, Iran
Actively Recruiting
Research Team
Z
Zahra Vahdat Shariatpanahi Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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