Refeeding SyndromeNCT05967858
Incidence of Refeeding Syndrome in Consecutively Admitted Patients
An observational study of Refeeding Syndrome and Starvation, run by Jens Rikardt Andersen.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refeeding Syndrome, Starvation, Phosphate Deficiency
- What is being tested?
- observation
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2013to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: No other than willingness to participate and consecutively admitted, as well as planned sufficient nutrition
Who may be able to join
- planned tube- or parenteral nutrition (complete or supplementary)
- > 18 years
- written consent
Who cannot join
- Renal insufficiency (p-creatinine >200 micromol/l)
- Lack of ability to communicate (registration of nutritional intake etc)
About this study
Official title: 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)
Read the 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)
- Conditions
- Refeeding Syndrome, Starvation, Phosphate Deficiency
- Being tested
- observation
- Medical subject headings
- Refeeding Syndrome, Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refeeding syndrome
No. patients with decrease in plasma phosphate + clinical symptoms
Measured: 1 week after start of nutrition
Secondary outcomes (1)
Refeeding phenomenon
No. patients with decrease in plasma phosphate after start of nutrition
Measured: 1 week after start of nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Dec 2013
- Primary completion31 May 2014
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refeeding SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- jens R Andersen, MD, MPA, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967858
- Sponsor's protocol ID
- norge refeed
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refeeding Syndrome - Incidence and Risk Factors: An Observational Study on Patients With G-I Disease and Head-neck Cancer
- ClinicalTrials.gov ID
- NCT05967858
- Acronym / sponsor ID
- norge refeed
- Conditions
- Refeeding Syndrome, Starvation, Phosphate Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 31 May 2014 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastroenterological | – | Other: observationConsecutive 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 |
| head and neck cancer | – | Other: observationConsecutive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No other than willingness to participate and consecutively admitted, as well as planned sufficient nutrition
Key inclusion criteria (3 listed)
- planned tube- or parenteral nutrition (complete or supplementary)
- > 18 years
- written consent
Key exclusion criteria (2 listed)
- Renal insufficiency (p-creatinine >200 micromol/l)
- Lack of ability to communicate (registration of nutritional intake etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationno intervention | Other | gastroenterological, head and neck cancer |
Primary outcome
Refeeding syndrome
Time frame: 1 week after start of nutrition
No. patients with decrease in plasma phosphate + clinical symptoms
1 secondary outcome
Refeeding phenomenon
Time frame: 1 week after start of nutrition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Refeeding Syndrome
Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
Refeeding Syndrome, Critical Illness
Not yet recruitingObservational study
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Not yet recruitingObservational study
Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome
Refeeding Syndrome, Malnutrition
Active, not recruitingPhase 1
Slow Introduction of Nutrition for Ill Malnourished Children
Malnutrition, Severe Acute, Malnutrition, Child
Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Critical Illness, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jens R Andersen, MD, MPA study chair
University of Copenhagen
Questions about this trial
What is this clinical trial studying?
An observational study of Refeeding Syndrome and Starvation, run by Jens Rikardt Andersen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refeeding syndrome (time frame: 1 week after start of nutrition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.