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RecruitingNCT06054139Updated Sep 26, 2023

Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit

An observational study in Refeeding Syndrome, sponsored by Samsun University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Samsun University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

Nutritional support is an important part of treatment in intensive care patients. Especially existing comorbidities and developing acute problems before intensive care admission can cause serious malnutrition for patients. Refeeding syndrome is a serious, life-threatening condition accompanied by electrolyte and metabolic disorders as a result of rapid re-feeding following prolonged starvation or malnutrition. The condition may be accompanied by electrolyte disorders such as hypophosphatemia, hypokalemia and hypomagnesemia, as well as decrease in vitamin levels (especially vitamin B1), fluid imbalance and salt retention. The resulting imbalances can cause cardiac and neurological side effects, impaired organ functions and even death. The refeeding protocol should be individualized to each patient's clinical situation. In this study, although nutritional protocols in accordance with the guidelines are applied in patients with risk factors for the development of Refeeding Syndrome, whether Refeeding Syndrome develops and the facilitating factors will be investigated in ICU.

02

Conditions studied

  • Refeeding Syndrome

Keywords

  • hypophosphatemia
  • hypomagnesemia
03

In context

Refeeding Syndrome

24 studies on the registry are indexed under Refeeding Syndrome; 7 are open to participants now.

This study's planned enrollment of 60 is close to the median of 57 across 16 observational studies indexed under Refeeding Syndrome.

Browse Refeeding Syndrome studies →

Lead sponsor

Samsun University is the lead sponsor of 89 studies on the registry; 20 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Adult patients receiving treatment in intensive care at Samsun University Hospital

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

  1. Patients are intensive care patients
  2. Patients' age > 18 -

Exclusion criteria

Exclusion Criteria:

  1. Diabetic ketoacidosis
  2. Other risk factors for hypophosphatemia (patients on continuous hemodialysis, hyperphosphatemia treatment, parathyroidectomy)
  3. Patients with pre-study hypophosphatemia (\< 0.65 mmol/L)
  4. Patients with hyperparathyroidism
  5. Terminal stage cancer patients
  6. Patients with Glasgow Coma Scale ≤5
  7. Patients with respiratory and metabolic alkalosis -
05

Study design

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

Groups and cohorts

  • the treated patients in ICU

    Patients receiving nutrition while receiving treatment in intensive care

    Other: Refeeding Syndrome

Interventions

  • OtherRefeeding Syndrome

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

06

What researchers measure

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

    Time frame: from june 9, 2023 to june 9, 2024

07

Study locations

1 of 1 sites recruiting
  • Şerife Seçgin
    Samsun, 55270, Turkey
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Jun 2024, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2023
First posted
Sep 26, 2023
StartActual
Jun 9, 2023
Primary completionEst.
Jun 9, 2024
CompletionEst.
Jul 9, 2024
Last update
Sep 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06054139
Lead sponsor
Samsun University
Responsible party
serife secgin (Specialist of Anaesthesiology and Reanimation Principle İnvestigator, Samsun University) — Principal investigator
First posted
Sep 26, 2023
Start date
Jun 9, 2023
Primary completion
Jun 9, 2024 (estimated)
Completion
Jul 9, 2024 (estimated)
Last update
Sep 26, 2023

Study contacts

ŞERİFE SEÇGİN
Contact
kuvez@hotmail.com
+905556166112
DİLAN AKYURT
Contact
dilanakyurt@gmail.com
+905062344791
ÖZGÜR KÖMÜRCÜ
study director · SAMSUN UNIVERSITY HOSPITAL

Oversight

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

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