NCT06054139

Brief Summary

Refeeding Syndrome is a condition that occurs when patients who are undernourished or undernourished suddenly start overfeeding, causing electrolyte disturbances and vitamin deficiencies, resulting in neurological and cardiac problems. It may even result in death. It is aimed to prevent the development of Refeeding Syndrome with nutrition in accordance with the guidelines. The aim of this study is to determine the risk factors for Refeeding Syndrome in Intensive Care Unit (ICU).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2024

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 19, 2023

Last Update Submit

September 19, 2023

Conditions

Keywords

hypophosphatemiahypomagnesemia

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Refeeding Syndrome

    Occurrence of RFS:Within 72 hours after feeding serum phosphorus \< 0.0.87mmol/L, or from the baseline levels drop \> 0.16% or drop \> 30%;And (or) hypokalemia, hypomagnesemia, hypocalcemia and corresponding clinical symptoms

    from june 9, 2023 to june 9, 2024

Study Arms (1)

the treated patients in ICU

Patients receiving nutrition while receiving treatment in intensive care

Other: Refeeding Syndrome

Interventions

Patients who developed Refeeding Syndrome despite proper nutrition while receiving treatment in the ICU

the treated patients in ICU

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients receiving treatment in intensive care at Samsun University Hospital

You may qualify if:

  • Patients are intensive care patients
  • Patients' age \> 18 -

You may not qualify if:

  • Diabetic ketoacidosis
  • Other risk factors for hypophosphatemia (patients on continuous hemodialysis, hyperphosphatemia treatment, parathyroidectomy)
  • Patients with pre-study hypophosphatemia (\< 0.65 mmol/L)
  • Patients with hyperparathyroidism
  • Terminal stage cancer patients
  • Patients with Glasgow Coma Scale ≤5
  • Patients with respiratory and metabolic alkalosis -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şerife Seçgin

Samsun, 55270, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Refeeding SyndromeHypophosphatemia

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesPhosphorus Metabolism DisordersMetabolic Diseases

Study Officials

  • ÖZGÜR KÖMÜRCÜ

    SAMSUN UNIVERSITY HOSPITAL

    STUDY DIRECTOR

Central Study Contacts

ŞERİFE SEÇGİN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Anaesthesiology and Reanimation Principle İnvestigator

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

June 9, 2023

Primary Completion

June 9, 2024

Study Completion

July 9, 2024

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations