NCT06583928

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

August 31, 2024

Last Update Submit

September 4, 2024

Conditions

Outcome Measures

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

    Basline

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Runde J, Sentongo T. Refeeding Syndrome. Pediatr Ann. 2019 Nov 1;48(11):e448-e454. doi: 10.3928/19382359-20191017-02.

    PMID: 31710364BACKGROUND
  • 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.

    PMID: 26597128BACKGROUND
  • 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.

    PMID: 18583681BACKGROUND

Related Links

MeSH Terms

Conditions

Refeeding Syndrome

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Fatma Abdelfatah Ali, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 31, 2024

First Posted

September 4, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09