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Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT06054139
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
serife secgin, Samsun University

Study Description
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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
Refeeding Syndrome 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
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Study Type : Observational
Estimated 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 : June 9, 2023
Estimated Primary Completion Date : June 9, 2024
Estimated Study Completion Date : July 9, 2024
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Occurrence of Refeeding Syndrome [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult patients receiving treatment in intensive care at Samsun University Hospital
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054139


Contacts
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Contact: ŞERİFE SEÇGİN +905556166112 kuvez@hotmail.com
Contact: DİLAN AKYURT +905062344791 dilanakyurt@gmail.com

Locations
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Turkey
Şerife Seçgin Recruiting
Samsun, Turkey, 55270
Contact: ŞERİFE SEÇGİN    +905556166112    kuvez@hotmail.com   
Sponsors and Collaborators
Samsun University
Investigators
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Study Director: ÖZGÜR KÖMÜRCÜ SAMSUN UNIVERSITY HOSPITAL
More Information
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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: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by serife secgin, Samsun University:
hypophosphatemia
hypomagnesemia
Additional relevant MeSH terms:
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Refeeding Syndrome
Syndrome
Disease
 Pathologic Processes
Malnutrition
Nutrition Disorders