- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06054139
Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit
September 19, 2023 updated by: serife secgin, Samsun University
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).
Study Overview
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 Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dilan Akyurt
- Phone Number: +905062344791
- Email: dilanakyurt@gmail.com
Study Contact Backup
- Name: ŞERİFE SEÇGİN
- Phone Number: +905556166112
- Email: kuvez@hotmail.com
Study Locations
-
-
-
Samsun, Turkey, 55270
- Recruiting
- Şerife Seçgin
-
Contact:
- ŞERİFE SEÇGİN
- Phone Number: +905556166112
- Email: kuvez@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Adult patients receiving treatment in intensive care at Samsun University Hospital
Description
Inclusion Criteria:
- Patients are intensive care patients
- Patients' age > 18 -
Exclusion Criteria:
- 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 -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
the treated patients in ICU
Patients receiving nutrition while receiving treatment in intensive care
|
Patients who developed Refeeding Syndrome despite proper nutrition while receiving treatment in the ICU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
from june 9, 2023 to june 9, 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ÖZGÜR KÖMÜRCÜ, SAMSUN UNIVERSITY HOSPITAL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2023
Primary Completion (Estimated)
June 9, 2024
Study Completion (Estimated)
July 9, 2024
Study Registration Dates
First Submitted
September 19, 2023
First Submitted That Met QC Criteria
September 19, 2023
First Posted (Actual)
September 26, 2023
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 19, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SÜKAEK-2023 12/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.