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

Comparing the Effects of High-protein Nutritional Support with Standard Protein Nutritional Support Through the Administration of Whey Protein Supplements on Clinical Outcomes of Critically Ill Patients At Risk for Refeeding Syndrome: a Randomized Comparative Clinical Trial

This study is testing whether giving critically ill patients more protein in their nutrition can help them recover better and avoid serious complications while in the ICU.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shahid Beheshti University (Academic / other)
• Locations: 1 site (Tehran)
• Trial ID: NCT06825377 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are critically ill patients aged 18 to 65 who are at risk for refeeding syndrome and can tolerate enteral nutrition.

Not a fit: Patients with active infections, severe organ failure, or those with specific conditions requiring different protein needs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved nutritional strategies that enhance recovery and reduce mortality in critically ill patients.

How similar studies have performed: While the approach of varying protein intake in critically ill patients is established, this specific comparison of high-protein versus standard protein nutritional support is novel.

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, 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 this trial is running

Tehran

• 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

Conditions Critical Illness; Malnutrition; Refeeding Syndrome; At Risk for Refeeding Syndrome; Refeeding syndrome; Critically ill; High-protein; Complication