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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05967858
Other study ID # norge refeed
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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