NCT05967858

Brief 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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2014

Completed
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

July 21, 2023

Last Update Submit

August 9, 2023

Conditions

Refeeding SyndromeStarvationPhosphate Deficiency

Outcome Measures

Primary Outcomes (1)

  • Refeeding syndrome

    No. patients with decrease in plasma phosphate + clinical symptoms

    1 week after start of nutrition

Secondary Outcomes (1)

  • Refeeding phenomenon

    1 week after start of nutrition

Study Arms (2)

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

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

Interventions

observationOTHER

no intervention

gastroenterologicalhead and neck cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Refeeding SyndromeStarvation

Interventions

Observation

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • jens R Andersen, MD, MPA

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 1, 2023

Study Start

December 1, 2013

Primary Completion

May 31, 2014

Study Completion

July 1, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share