Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589479
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Prevention of Refeeding Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Different Caloric Density Intake in Prevention of Refeeding Syndrome in Critically Ill Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children
Detailed Description:
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 llnessesvarious 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 eg congenital heart disease Advanced neurologic impairment Eating disorderseg anorexia nervosa Dysphagia Gastrointestinal dysmotility Malabsorption eg 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 gt7-10 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None