Incidence of Refeeding Syndrome in Consecutively Admitted Patients

Starvation Clinical Trial

Official title:

Refeeding Syndrome - Incidence and Risk Factors: An Observational Study on Patients With G-I Disease and Head-neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05967858
• Other study ID #: norge refeed
• Status: Completed
• Start date: December 1, 2013
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The incidence and main risk-factors analyzed in consecutive in-patients in the departments og gastroenterology and ear-nose and throat diseases (cancer in radiation therapy)

Description:

Patients with either parenteral- or tube feeding enter the study to assure sufficient nutrition. During hospitalization patients were monitored with daily blood samples and clinical evaluation of symptoms in addition to the coverage of energy and protein in percent of estimated needs. Refeeding phenomenon was defined as a decrease in plasma phosphate after the initiation of nutrition. Refeeding syndrome as refeeding phenomenon and one or more relevant symptoms in addition (hypotension, cardiac arrhythmia, edema, confusion)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 1, 2023
• Est. primary completion date: May 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• planned tube- or parenteral nutrition (complete or supplementary)
• > 18 years
• written consent

Exclusion Criteria:

• Renal insufficiency (p-creatinine >200 micromol/l)
• Lack of ability to communicate (registration of nutritional intake etc)

Related Conditions & MeSH terms

• Phosphate Deficiency
• Refeeding Syndrome
• Starvation
• Syndrome

Intervention

Other:
• observation
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jens Rikardt Andersen	St. Olavs Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refeeding syndrome	No. patients with decrease in plasma phosphate + clinical symptoms	1 week after start of nutrition
Secondary	Refeeding phenomenon	No. patients with decrease in plasma phosphate after start of nutrition	1 week after start of nutrition