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

RecruitingNAAges 18 Years - 65 YearsAllShahid Beheshti University
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Willingness to cooperate and complete the informed consent form by the patient or legal guardian; * age โ‰ค 18 years and \< 65 years; * Non-pregnant and non-lactating; * Serum creatinine โ‰ฅ 1.1 mg/dl for women and โ‰ฅ 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
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What it tests

  • Whey protein
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Where

1 site
Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences
Tehran, Iran
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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