ClinicalTrials.gg
Status unknownNCT06583928Updated Sep 19, 2024

Refeeding Syndrome in Critically Ill Children

An observational study in Refeeding Syndrome and Syndrome, Refeeding, sponsored by Assiut University. Status unknown. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
1 Month to 18 Years
Sex
All
01

Study summary

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.

Read the 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.

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.

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.

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.

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.

02

Conditions studied

  • Refeeding Syndrome
  • Syndrome, Refeeding

Browse trials for

03

In context

Refeeding Syndrome

21 studies on the registry are indexed under Refeeding Syndrome; 6 are open to participants now.

This study's planned enrollment of 54 is close to the median of 53 across 14 observational studies indexed under Refeeding Syndrome.

Browse Refeeding Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients age less than 1month and more than 18 years' old and patients with CKD ,liver cirrhosis and endocrinal diseases.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Runde J, Sentongo T. Refeeding Syndrome. Pediatr Ann. 2019 Nov 1;48(11):e448-e454. doi: 10.3928/19382359-20191017-02. PubMed 31710364 ↗
  • Doig GS, Simpson F, Heighes PT, Bellomo R, Chesher D, Caterson ID, Reade MC, Harrigan PW; Refeeding Syndrome Trial Investigators Group. Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults: a randomised, parallel-group, multicentre, single-blind controlled trial. Lancet Respir Med. 2015 Dec;3(12):943-52. doi: 10.1016/S2213-2600(15)00418-X. Epub 2015 Nov 18. PubMed 26597128 ↗
  • Mehanna HM, Moledina J, Travis J. Refeeding syndrome: what it is, and how to prevent and treat it. BMJ. 2008 Jun 28;336(7659):1495-8. doi: 10.1136/bmj.a301. No abstract available. PubMed 18583681 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06583928
Lead sponsor
Assiut University
Responsible party
Manal Mohamed Ali (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 4, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Oct 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Manal Mohamed Ali
Contact
manalmohamedali411@gmail.com
+20116460406
Fatma Abdelfatah Ali, Professor
Contact
Fatmaalius@yahoo.com
+201006347038

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion