RecruitingNot Applicable

Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome

Iran150 participantsStarted 2025-02-13

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, or acidosis. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with refeeding syndrome

Timeframe: within the first 5-7 days of nutrition delivery

Trial details

NCT IDNCT06825377

SponsorShahid Beheshti University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-15

Contact for this trial

Zahra Vahdat Shariatpanahi Professor

0098-021-22357484 nutritiondata@yahoo.com

View on ClinicalTrials.gov More Critical Illness trials