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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.
Patients will be randomly assigned to two groups: the high-protein group and the standard-protein group. Upon ICU admission, and after meeting the inclusion criteria and identifying a risk of refeeding syndrome (RS), they will be allocated to one of the two groups. Patient selection for RS risk will be based on the diagnostic criteria outlined in the 2020 ASPEN guidelines. The m-NUTRIC and APACHE II scores will be calculated for all patients at ICU admission and 24 hours before the initiation of feeding. Monitoring for multi-organ dysfunction syndrome (MODS) will involve daily laboratory tests and organ failure assessment using the SOFA score.
Before starting the nutritional intervention, all patients will receive 100 mg of thiamine daily for one week, along with a daily multivitamin-mineral supplement. Due to the risk of RS, calorie intake will begin at low levels and will be cautiously increased in both groups. To calculate the energy needs, ideal body weight will be used. In the high-protein group, the target protein intake will be 2 grams per kilogram of body weight per day, while in the standard-protein group, it will be 1.3 grams per kilogram of body weight per day. Protein will be introduced gradually, starting from a low level, as part of nutritional support, with whey protein powder added if needed as a supplement. If serum creatinine levels rise, protein powder will be removed from the patient's diet. The intervention duration will be 14 days, with a minimum of 5 days.
The primary clinical outcome is the incidence of refeeding syndrome (RS), while secondary outcomes include the occurrence of infections, hospital length of stay, ICU length of stay, multi-organ failure, and mortality within 45 days of admission. RS will be diagnosed according to the 2020 ASPEN guidelines. Serum concentrations of potassium, magnesium, phosphate, glucose, urea, and creatinine will be measured daily for one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-protein | Experimental | The target protein intake of 2 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement. |
|
| Standard-protein | Active Comparator | The target protein intake of 1.3 grams per kilogram of body weight per day will be gradually introduced, starting at a low level, through nutritional support, with whey protein powder added if needed as a supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | Whey protein powder will be provided with nutritional support in both groups if needed to meet the target protein intake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with refeeding syndrome | Refeeding syndrome will be diagnosed based on a decrease in serum levels of electrolytes, including potassium, magnesium, and phosphate, within the first 5 days of nutrition delivery. | within the first 5-7 days of nutrition delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infection | Determining and comparing the incidence of infection and its duration | Within 5-14 days of nutrition delivery |
| Number of participants with organ failure as measured by SOFA score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zahra Vahdat Shariatpanahi Professor | Contact | 0098-021-22357484 | nutritiondata@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Zahra Vahdat Shariatpanahi Professor | School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences | Recruiting | Tehran | Iran |
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Organ failure will be assessed using the SOFA Score (Sequential Organ Failure Assessment), which evaluates the function of the following organ systems:
Cardiovascular Respiratory Renal Hepatic Coagulation Neurological
| Within 5-14 days of nutrition delivery |
| Duration of ICU stay | up to 7 weeks after admission |
| Duration of hospital stay | up to 7 weeks after admission |
| Mortality | 45-day mortality from the time of ICU admission | up to 45-day |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D044342 | Malnutrition |
| D055677 | Refeeding Syndrome |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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