Clinical trial NCT06825377: Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Malnutrition
Refeeding Syndrome
At Risk for Refeeding Syndrome
Keywords: Refeeding syndrome
Critically ill
High-protein
Complication
Malnutrition
mortality
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of participants with refeeding syndrome
timeFrame: within the first 5-7 days of nutrition delivery
Secondary outcomes:
measure: Incidence of infection
timeFrame: Within 5-14 days of nutrition delivery
measure: Number of participants with organ failure as measured by SOFA score
timeFrame: Within 5-14 days of nutrition delivery
measure: Duration of ICU stay
timeFrame: up to 7 weeks after admission
measure: Duration of hospital stay
timeFrame: up to 7 weeks after admission
measure: Mortality
timeFrame: up to 45-day
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ayatollah Taleghani Medical, Educational, and Therapeutic Center, Shahid Beheshti University of Medical Sciences
Study officials:
affiliation: School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
name: Zahra Vahdat Shariatpanahi Professor
role: PRINCIPAL_INVESTIGATOR
References: