Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit

Sponsor
Samsun University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06054139
Collaborator
(none)
60
1
13
4.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Refeeding Syndrome

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit
Actual Study Start Date :
Jun 9, 2023
Anticipated Primary Completion Date :
Jun 9, 2024
Anticipated Study Completion Date :
Jul 9, 2024

Arms and Interventions

Arm Intervention/Treatment
the treated patients in ICU

Patients receiving nutrition while receiving treatment in intensive care

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

Outcome Measures

Primary Outcome Measures

  1. Occurrence of Refeeding Syndrome [from june 9, 2023 to june 9, 2024]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Patients are intensive care patients

  2. Patients' age > 18 -

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 -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Şerife Seçgin Samsun Turkey 55270

Sponsors and Collaborators

  • Samsun University

Investigators

  • Study Director: ÖZGÜR KÖMÜRCÜ, SAMSUN UNIVERSITY HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
serife secgin, Specialist of Anaesthesiology and Reanimation Principle İnvestigator, Samsun University
ClinicalTrials.gov Identifier:
NCT06054139
Other Study ID Numbers:
  • SÜKAEK-2023 12/20
First Posted:
Sep 26, 2023
Last Update Posted:
Sep 26, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by serife secgin, Specialist of Anaesthesiology and Reanimation Principle İnvestigator, Samsun University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2023