Refeeding SyndromeNCT06054139
Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit
An observational study of Refeeding Syndrome, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refeeding Syndrome
- What is being tested?
- Refeeding Syndrome
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jun 2023to 9 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients receiving treatment in intensive care at Samsun University Hospital
Who may be able to join
- Patients are intensive care patients
- Patients' age > 18 -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şerife Seçgin
Samsun, 55270
ŞERİFE SEÇGİN, +905556166112, kuvez@hotmail.com
About this study
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.
- Conditions
- Refeeding Syndrome
- Being tested
- Refeeding Syndrome
- Keywords
- hypophosphatemia, hypomagnesemia
- Medical subject headings
- Refeeding Syndrome, Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refeeding SyndromeOther
Patients who developed Refeeding Syndrome despite proper nutrition while receiving treatment in the ICU
| Study group | Role | What they receive |
|---|---|---|
| the treated patients in ICU | Patients receiving nutrition while receiving treatment in intensive care Receives: Other: Refeeding Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from june 9, 2023 to june 9, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start9 Jun 2023
- Primary completion9 Jun 2024 (estimated)
- Study completion9 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refeeding SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, serife secgin, Samsun University
- Investigators
- ÖZGÜR KÖMÜRCÜ, Study director, SAMSUN UNIVERSITY HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054139
- Sponsor's protocol ID
- SÜKAEK-2023 12/20
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06054139
- Acronym / sponsor ID
- SÜKAEK-2023 12/20
- Conditions
- Refeeding Syndrome
- Keywords
- hypophosphatemia, hypomagnesemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 9 Jun 2024 (estimated)
- Study completion
- 9 Jul 2024 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the treated patients in ICU | – | Other: Refeeding SyndromePatients receiving nutrition while receiving treatment in intensive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving treatment in intensive care at Samsun University Hospital
Key inclusion criteria (2 listed)
- Patients are intensive care patients
- Patients' age > 18 -
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refeeding SyndromePatients who developed Refeeding Syndrome despite proper nutrition while receiving treatment in the ICU | Other | the treated patients in ICU |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
Related trials for Refeeding Syndrome
Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
Refeeding Syndrome, Critical Illness
Not yet recruitingObservational study
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Not yet recruitingObservational study
Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome
Refeeding Syndrome, Malnutrition
Active, not recruitingPhase 1
Slow Introduction of Nutrition for Ill Malnourished Children
Malnutrition, Severe Acute, Malnutrition, Child
Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Critical Illness, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ÖZGÜR KÖMÜRCÜ study director
SAMSUN UNIVERSITY HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refeeding Syndrome, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ŞERİFE SEÇGİN (+905556166112, kuvez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Refeeding Syndrome (time frame: from june 9, 2023 to june 9, 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.