Comparing high-protein and standard protein nutrition for critically ill patients at risk for refeeding syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to identify the best protein administration strategy to improve nutritional and clinical outcomes while reducing complications and mortality in ICU patients at risk for refeeding syndrome. Participants will be randomly assigned to receive either high-protein or standard-protein nutritional support upon ICU admission. The study will monitor various health metrics, including multi-organ dysfunction syndrome and protein intake levels, over a 14-day intervention period. The primary hypothesis is that higher protein intake will lead to fewer cases of refeeding syndrome and better overall health outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences
  Tehran, Iran Recruiting

Study contacts

• Principal investigator: Zahra Vahdat Shariatpanahi Professor — School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
• Study coordinator: Zahra Vahdat Shariatpanahi Professor
• Email: nutritiondata@yahoo.com
• Phone: 0098-021-22357484

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Optimized nutritional therapy with early physiotherapy for long-stay ICU patients

  This program tests whether better-tailored nutrition combined with early physiotherapy helps adults on ventilators who are expected to stay in the ICU seven days or more leave the hospital with stronger muscles.

  Recruiting University Hospital, Geneva · Geneva, Canton of Geneva · NCT05865314

• Predicting Extubation Problems With Machine Learning

  This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.

  Recruiting Universitas Indonesia · Jakarta, DKI Jakarta and 1 other locations · NCT07918924

• Levetiracetam Dosing in Critically Ill on CRRT

  This study tests how levetiracetam behaves in the bodies of adults on continuous renal replacement therapy to help figure out the best dosing.

  Recruiting Chulalongkorn University · Pathum Wan, Bangkok · NCT07918833

• Respiratory Physiotherapy in Critically Ill Pneumonia Patients

  This study tests whether a structured breathing and chest therapy program can change inflammatory biomarkers in adults with pneumonia in the ICU compared to usual care.

  Recruiting Hospital H+ Queretaro · Querétaro · NCT07909616

• Immersive VR for improving upper limb function in critically ill ICU patients

  This trial tests whether fully immersive virtual reality training added to standard ICU rehabilitation can help improve upper limb strength and coordination in adults with ICU-acquired weakness.

  Recruiting National and Kapodistrian University of Athens · Athens, Attica · NCT07901855

• Cycling with immersive VR for ICU patients recovering from critical illness

  In this crossover study, critically ill adults in the ICU will try three 10-minute cycling sessions to see if an immersive VR environment motivates them more than cycling with no visuals or cycling while watching a route on a TV.

  Recruiting KU Leuven · Leuven · NCT07894146

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.