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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants with refeeding syndrome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of participants with refeeding syndrome
时间窗: within the first 5-7 days of nutrition delivery
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.
次要结局
- Incidence of infection(Within 5-14 days of nutrition delivery)
- Number of participants with organ failure as measured by SOFA score(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(up to 45-day)
研究者
Zahra Vahdat Shariatpanahi
Associate professor
Shahid Beheshti University of Medical Sciences