Actively Recruiting
Comparing the Effects of High-protein Nutritional Support with Standard Protein Nutritional Support Using Whey Protein Supplements on Outcomes of Critically Ill Patients At Risk for Refeeding Syndrome
Led by Shahid Beheshti University · Updated on 2025-02-14
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is focused on critically ill patients who are at risk for refeeding syndrome (RS) and are receiving supportive nutrition in an ICU setting. Researchers aim to find the best protein administration method to improve nutritional and clinical outcomes, reduce complications, and lower mortality. The study tests the hypothesis that a higher protein intake may decrease the occurrence of refeeding syndrome and improve overall patient outcomes, including shorter ICU and hospital stays. Participants are randomly assigned to either a high-protein group or a standard-protein group. Both groups receive nutritional support starting with low calorie intake that gradually increases. The high-protein group targets 2 grams of protein per kilogram of body weight per day, while the standard-protein group targets 1.3 grams per kilogram per day. Protein is gradually introduced, with whey protein powder added if needed, and the intervention lasts for 14 days with a minimum of 5 days. All patients receive daily thiamine and multivitamin-mineral supplements during the study. During the trial, patients are closely monitored with daily laboratory tests for key blood levels and organ function using scoring systems like SOFA. Researchers track the number of patients who develop refeeding syndrome within the first week, as well as secondary outcomes like infections, organ failure, length of ICU and hospital stays, and mortality up to 45 days after admission. The study involves regular assessments and careful monitoring to understand the effects of protein intake on these critically ill patients.
CONDITIONS
Brief 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 sign informed consent 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 at the time of enrollment
- Start of intervention 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 or gastrointestinal ischemia
- No active infections, sepsis, severe sepsis, or septic shock
- No intolerance to the whey protein supplement
- Not participating in other clinical trials at the same time
- No clinical conditions requiring different protein needs such as burns, sepsis, cirrhosis, or chronic kidney disease
- No diabetes with severe complications like ketoacidosis or hyperosmolar coma
You will not qualify if you...
- Unwillingness to continue participation during the study
- Discharge or death within 5 days of starting the intervention
- Occurrence of side effects during the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Minimum of 5 days, up to 14 days
Participants receive nutritional support with either high-protein or standard-protein intake using whey protein supplements as needed. Protein intake is gradually introduced starting at a low level, with monitoring of serum creatinine to adjust supplementation. All participants receive thiamine and multivitamin-mineral supplements daily before starting nutrition. Calorie intake begins low and increases cautiously due to risk of refeeding syndrome.
Daily visits for monitoring during the treatment period
Duration - Up to 45 days after admission
Participants are monitored for clinical outcomes including refeeding syndrome, infections, organ failure, ICU and hospital length of stay, and mortality up to 45 days after admission.
Regular assessments during ICU and hospital stay up to 7 weeks; mortality monitored up to 45 days
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
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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