Refeeding Syndrome in Critically Ill Children

August 31, 2024 updated by: Manal Mohamed Ali, Assiut University

Frequency of Refeeding Syndrome in Critically Ill Children At Assiut University Hospital

Refeeding syndrome (RFS) is the a metabolic disturbance which occurs as a result of reinstitution of nutrition in people who are starved, severely malnourished, or metabolically stressed because of severe illness. When too much food or liquid nutrition supplement is eaten during the initial three to seven days following a malnutrition event, the production of glycogen, fat and protein in cells may cause low serum concentrations of potassium, magnesium and phosphate.[1][2]

Study Overview

Status

Not yet recruiting

Detailed Description

Refeeding syndrome (RFS) is the a metabolic disturbance which occurs as a result of reinstitution of nutrition in people who are starved, severely malnourished, or metabolically stressed because of severe illness. When too much food or liquid nutrition supplement is eaten during the initial three to seven days following a malnutrition event, the production of glycogen, fat and protein in cells may cause low serum concentrations of potassium, magnesium and phosphate.[1][2] When risk factors are not identified and nutrition therapy is not managed appropriately, devastating consequences such as electrolyte depletion and imbalances, fluid overload, arrhythmia, seizure, encephalopathy, and death may occur.[3] Once nutrition is reintroduced to a patient who has been starved for an extended period, anabolism begins directly . The body shifts back to carbohydrate metabolism from protein and fat catabolism, and glucose becomes the primary source of energy once again. The increased glucose load, with a corresponding increase in the release of insulin, leads to cellular uptake of glucose, potassium, magnesium,and phosphate. This shift of electrolytes back into the cell causes,hypokalemia,hypomagnesemia, and hypophosphatemia. Insulin also exhibits a natriuretic effect on the kidneys. Hence, sodium is retained, causing fluid retention and expansion of the extracellular fluid volume.[4-5] Hypophosphatemia is the hallmark of RFS. Other electrolyte abnormalities are associated with RFS, however, such as hypokalemia and hypomagnesemia. Shifts in glucose, sodium, and fluid balance are also seen in RFS. Consequently, cardiovascular, pulmonary, neuromuscular, hematologic, and gastrointestinal complications occur.

This syndrome can emerge with aggressive oral nutrition, enteral nutrition, or PN and can be fatal if not recognized and treated in a timely manner.[6] Refeeding syndrome can be fatal if not recognized and treated properly. The electrolyte disturbances of the refeeding syndrome can occur within the first few days of refeeding. Close monitoring of blood biochemistry is therefore necessary in the early refeeding period.

A Data on RFS incidence is lacking, and the heterogeneity of diagnostic criteria and frequent electrolyte disorders in this population make its diagnosis complex. In 2020, the American Society for Parenteral and Enteral Nutrition (ASPEN) developed consensus recommendations for identifying patients at risk and with refeeding syndrome. These state that undernourished children are considered at risk of refeeding syndrome; those who develop one significant electrolyte disorder (decrease ≥ 10% in phosphorus, potassium, and/or magnesium) within the first five days of nutritional support, combined with a significant increase in energy intake, are considered to have refeeding syndrome. [7]

Study Type

Observational

Enrollment (Estimated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

- Children (1month to 18 years) admitted at hospital with minimum of one phosphorus, potassium, and/or magnesium assay and who are severely malnourished and starved (no feeding )for at least 3 days then received exclusive or supplemental nutritional support.

Undernourished children (body mass index z-score < -2 standard deviations) were considered at risk of refeeding syndrome. The ASPEN critiera were used to identify those with probable refeeding syndrome.

Description

Inclusion Criteria:

  • Children included were those (1month to 18 years) admitted at hospital with minimum of one phosphorus, potassium, and/or magnesium assay and who are severely malnourished and starved (no feeding )for at least 3 days then received exclusive or supplemental nutritional support.

Undernourished children (body mass index z-score < -2 standard deviations) were considered at risk of refeeding syndrome. The ASPEN critiera were used to identify those with probable refeeding syndrome.

Exclusion Criteria:

  • Patients age less than 1month and more than 18 years' old and patients with CKD ,liver cirrhosis and endocrinal diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the numbers of patients who developed refeeding syndrome according to ASPEN criteria , those who develop one significant electrolyte disorder (decrease ≥ 10% in phosphorus, potassium, and/or magnesium) within the first
Time Frame: Basline
Basline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 31, 2024

First Submitted That Met QC Criteria

August 31, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 31, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Frequency of refeeding syndrom

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refeeding Syndrome

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