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

Launched by SHAHID BEHESHTI UNIVERSITY · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to provide protein nutrition to critically ill patients who may be at risk for a condition called refeeding syndrome, which can occur when someone who has been malnourished starts to eat again. The goal is to see if giving patients a higher amount of protein can lead to better health outcomes, such as fewer complications, lower chances of death, and shorter stays in the intensive care unit (ICU) and hospital. Researchers believe that by focusing on protein intake, they can improve recovery for these patients.

To participate in this study, patients should be between the ages of 18 and 65, be willing to provide consent, and have no serious health issues like organ failure or active infections. If eligible, participants can expect to receive nutritional support in the form of protein supplements while being closely monitored for any side effects. This study aims to learn how nutrition can help improve the health of critically ill patients and potentially change how they are treated in the future.

Gender

ALL

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