Incidence of Refeeding Syndrome in Consecutively Admitted Patients

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

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)

Study Overview

• Status: Completed
• Conditions: Starvation; Refeeding Syndrome; Phosphate Deficiency
• Intervention / Treatment: Other: observation

Detailed 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)

• Study Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

No other than willingness to participate and consecutively admitted, as well as planned sufficient nutrition

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
gastroenterological; Consecutive admissions - n= 43 - 34 operated (79%) - 10 patients acutely admitted Diseases in Esophagus (8), gastric cavity (8), pancreas (7), colon/rectum (8), bile (4), small intestine (3), IBD (5) No interventions in the treatments, just observation	Other: observation; no intervention
head and neck cancer; Consecutive admissions - n=8 - 7 radiation therapy - 1 operated Locations: 2 Larynx, 1 oro-pharynx, 4 tonsillar, 1 tung No interventions in the treatments, just observation	Other: observation; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refeeding syndrome	No. patients with decrease in plasma phosphate + clinical symptoms	1 week after start of nutrition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refeeding phenomenon	No. patients with decrease in plasma phosphate after start of nutrition	1 week after start of nutrition

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Collaborators: St. Olavs Hospital
• Investigators: Study Chair: Jens R Andersen, MD, MPA, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): May 31, 2014
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Nutrition Disorders; Malnutrition; Syndrome; Starvation; Refeeding Syndrome
• Other Study ID Numbers: norge refeed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No