Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit

Refeeding Syndrome Clinical Trial

Official title:

Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054139
• Other study ID #: SÜKAEK-2023 12/20
• Status: Recruiting
• Start date: June 9, 2023
• Est. completion date: July 9, 2024

Study information

• Verified date: September 2023
• Source: Samsun University
• Contact: SERIFE SEÇGIN
• Phone: +905556166112
• Email: kuvez[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 9, 2024
• Est. primary completion date: June 9, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Refeeding Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Serife Seçgin	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from june 9, 2023 to june 9, 2024