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临床试验/NCT06589479
NCT06589479尚未招募不适用

Effects of Different Caloric Density Intake in Prevention of Refeeding Syndrome in Critically Ill Children

Assiut University0 个研究点目标入组 50 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Prevention of refeeding syndrome in critically ill children

研究概览

简要总结

To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children

详细描述

Refeeding syndrome, a critical condition in undernourished patients, is characterized by metabolic and electrolyte imbalances that occur upon reintroducing nutrition after a period of prolonged fasting which can lead to a sharp increase in morbidity and mortality rates following their release and the resumption of a normal diet. The occurrence of refeeding syndrome is well-documented in conditions such as anorexia nervosa. However, its prevalence among critically ill pediatric patients remains unclear. These patients often suffer from undernutrition due to chronic llnesses,various congenital and acquired diseases, malabsorption, or child abuse [2] There is an increasing awareness of the unexpectedly high prevalence of undernutrition and refeeding syndrome in this population. Studies indicate that between 13% and 20% of patients admitted to pediatric critical care units are undernourished [3] The early initiation of enteral nutrition is often recommended for its overall benefits in critically ill children However, it may inadvertently increase the risk of refeeding syndrome. Extended periods of starvation eventually result in the depletion of stored energy, along with a critical reduction in micronutrients and electrolytes, particularly phosphate, potassium, and magnesium. [5] Upon refeeding, there is an immediate transition from a catabolic to an anabolic state, marked by a rapid increase in caloric intake and a subsequent rise in insulin secretion. This increase in insulin enhances glycolysis-the process of breaking down glucose for energy. The resulting spike in insulin levels can lead to hypoglycemia and promote the transfer of electrolytes from the extracellular to the intracellular space. This movement can significantly reduce extracellular concentrations of potassium, phosphate, magnesium, and thiamine, which acts as a coenzyme. Given the pre-existing deficiencies in these electrolytes and micronutrients due to prolonged starvation, their levels can quickly fall as they are consumed during the metabolic response to refeeding. This abrupt change can precipitate severe complications associated with refeeding syndrome, which stem from imbalances and deficiencies in electrolyte and micronutrient levels Conditions that place critically ill children at high risk for refeeding syndrome . Clinical conditions Chronic critical illness (e.g., congenital heart disease) . Advanced neurologic impairment Eating disorders(e.g., anorexia nervosa) . Dysphagia Gastrointestinal dysmotility Malabsorption (e.g., short bowel syndrome, inflammatory bowel disease, chronic pancreatitis, cystic fibrosis) . Malignancy Child abuse Significant vomiting and diarrhea Unintentional . weight loss of 5%-10% of body weight in 1-6 months . Prolonged fasting >7-10 days . Inadequate nutritional intake for 10 day The clinical presentations of refeeding syndrome, which typically manifest in the initial days of nutritional reintroduction, include disturbances in fluid balance, hypoglycemia, hypophosphatemia, hypomagnesemia, hypokalemia, and thiamine deficiency. This syndrome can lead to a range of symptoms that affect the neurological, cardiac, hematological, and gastrointestinal systems, primarily due to electrolyte imbalances. To manage refeeding syndrome in at-risk patients, a gradual and cautious reintroduction of nutrition is advised. The cornerstone of reintroducing nutrition is to incrementally increase caloric intake over a period of several days. It is crucial to monitor serum electrolytes, particularly phosphorus, potassium, and magnesium, and provide supplementation as necessary. If patients exhibit signs of intolerance to the calories despite these precautions, it is advisable to temporarily reduce or maintain the caloric intake at its current level. Once the patients condition has stabilized, a careful and gradual increase in caloric intake may be continued. Additionally, thiamine supplementation is important due to its essential role in carbohydrate metabolism.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Month 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Chidren from one month up to less than 5 years.
  • Starvation (long term parenteral or IV fluid) for at least 3 days.
  • Patients at risk of refeeding syndrome according to ASPEN criteria.[11]

排除标准

  • Children below one month and above 5 years.
  • Carless or lack of compliance of parents or psychological problems.

结局指标

主要结局

Prevention of refeeding syndrome in critically ill children

时间窗: Baseli

Describe the pathophysiology of refeeding syndrome, and provide practical recommendations for its preventio in paediatric intensive care units (PICUs). The refeeding syndrome appears in patients who have had a reintroduced and/or increase caloric intake after a period of restricted or no caloric intake. It is manifested by a decrease in one or many electrolytes (potassium, magnesium and/or phosphorous), a thiamine deficiency and/or sodium retention. Despite the lack of evidence, the patients most at risk for refeeding syndrome seem to be malnourished children and those with restricted nutritional intake for more than 7 days. On admission to PICU, nutritional status should be assessed, this will include anthropometric measurements (weight and height z-score, mid upper arm circumference and head circumference in young children) and a diet history.

Methods

时间窗: Baseline

Data of the patients will be collected in the form of full history taking: Personal history:(age,sex) demographics including residence and socioeconomic status. Nutritional history : type of feeding and its concentration, frequency, amount And if there is any intolerance . Perinatal history(full term or preterm, type of delivery, NICU admission). Present history(disease type, onset, course \& duration) Feeding history(breast feeding, suckling power \& formula feeding). Calories will calculated in different categories patients. Daily monitoring weight by intake, output

Investigation

时间窗: Baseline

* CBC * Random blood glucose * Electrolyte /24 hours * Liver function * kidney function * If other investigation or imaging study already done will be recorded.

Sample Size Calculation

时间窗: Baseline

Based on determining the main outcome variable, The estimated minimum required sample size is 50 patients . The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is to determine effects of different caloric density intake in management of refeeding syndrome in critically ill children Based on literature review (\[10\] we hypothesized to find medium effect size, and based on the percentage confidence limits of 6% and a Confidence level=80% . Based on determining the main outcome variable, The estimated minimum required sample size is 50 patients . The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is to determine effects of different caloric density intake.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Ahmed Mohamed Khamis

71515,Assiut

Assiut University

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