Refeeding SyndromeRLSNCT04966780
Refeeding Like Syndrome in Acute Disease
An observational study of Refeeding Syndrome and Acute Abdomen, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial summary
The refeeding syndrome has been reported without any evidence of prolopnged semistarvation, thus being different from the traditional disease. The investigators wanted to investigate, if sodium infusions could be part of the explanation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refeeding Syndrome, Acute Abdomen
- What is being tested?
- acute abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2018to 1 Jun 2021
- 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: Consecutive, adult patients for acute, abdominal surgery were asked top be included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.
Who may be able to join
- age > 18 yr
- ready for acute surgery
- able to understand and cooperate.
Who cannot join
- pregnancy or breastfeeding
- renal insufficiency (p-creatinine>400 micr mol/l)
- re-operations
- expected hospital stay < 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-response Relation Between the Development of a Refeeding-like Syndrome and Sodium Balance in Patients Undergoing Acute Abdominal Surgery
The refeeding syndrome has been reported without any evidence of prolopnged semistarvation, thus being different from the traditional disease.
The investigators wanted to investigate, if sodium infusions could be part of the explanation.
Read the detailed description
Background: Refeeding syndrome is conventionally connected to start of feeding after prolonged periods of semi-starvation and adaption. However, it is also described in acutely ill patients and in ICU patients without a history of adaption, but sometimes only defined as a drop in p-phosphate without clinical manifestations. The investigators hypothesize, that a positive sodium balance could induce the refeeding-like syndrome (RLS).
Method: Consecutive patients for acute, abdominal surgery were included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.
- Conditions
- Refeeding Syndrome, Acute Abdomen
- Being tested
- acute abdominal surgery
- Keywords
- refeeding syndrome, acute abdominal disease
- Medical subject headings
- Refeeding Syndrome, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute abdominal surgeryProcedure or surgery
Acute surgery for acute abdominal disease
What is being measured
The primary outcome is the main question the study is designed to answer.
sodium balance
correlation between sodium balance and occurrence of the refeeding syndrome
Measured: 7 days
Secondary outcomes (3)
plasma phosphate
correlation between sodium balance and change in plasma phosphate
Measured: 7 days
urinary excretion of phosphate
correletion between sodium balance and urinary excretion of phosphate
Measured: 7 days
phosphate balance
correlation between decline in plasma phosphate and urinary excretion of phosphate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Apr 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- jens R Andersen, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966780
- Sponsor's protocol ID
- RLS in surgery
- Acronym
- RLS
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mikkelsen KK, Djurhuus M, Ritz C, Lin VA, Boel T, Voldby AW, Andersen JR. Associations between positive sodium balance and a refeeding-like syndrome following acute abdominal surgery: A prospective cohort study. Clin Nutr ESPEN. 2026 Jun;73:103297. doi: 10.1016/j.clnesp.2026.103297. Epub 2026 Apr 24.
PubMed 42036070
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Relation Between the Development of a Refeeding-like Syndrome and Sodium Balance in Patients Undergoing Acute Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04966780
- Acronym / sponsor ID
- RLS / RLS in surgery
- Conditions
- Refeeding Syndrome, Acute Abdomen
- Keywords
- refeeding syndrome, acute abdominal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Jul 2021 (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 refeeding syndrome has been reported without any evidence of prolopnged semistarvation, thus being different from the traditional disease.
The investigators wanted to investigate, if sodium infusions could be part of the explanation.
Detailed description
Background: Refeeding syndrome is conventionally connected to start of feeding after prolonged periods of semi-starvation and adaption. However, it is also described in acutely ill patients and in ICU patients without a history of adaption, but sometimes only defined as a drop in p-phosphate without clinical manifestations. The investigators hypothesize, that a positive sodium balance could induce the refeeding-like syndrome (RLS).
Method: Consecutive patients for acute, abdominal surgery were included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive, adult patients for acute, abdominal surgery were asked top be included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.
Key inclusion criteria (3 listed)
- age > 18 yr
- ready for acute surgery
- able to understand and cooperate.
Key exclusion criteria (4 listed)
- pregnancy or breastfeeding
- renal insufficiency (p-creatinine>400 micr mol/l)
- re-operations
- expected hospital stay < 24 hours.
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 |
|---|---|---|
| acute abdominal surgeryAcute surgery for acute abdominal disease | Procedure or surgery | – |
Primary outcome
sodium balance
Time frame: 7 days
correlation between sodium balance and occurrence of the refeeding syndrome
3 secondary outcomes
plasma phosphate
Time frame: 7 days
urinary excretion of phosphate
Time frame: 7 days
phosphate balance
Time frame: 7 days
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 26 Jul 2021.
- Derived from this study: PubMed 42036070Mikkelsen KK, Djurhuus M, Ritz C, Lin VA, Boel T, Voldby AW, Andersen JR. Associations between positive sodium balance and a refeeding-like syndrome following acute abdominal surgery: A prospective cohort study. Clin Nutr ESPEN. 2026 Jun;73:103297. doi: 10.1016/j.clnesp.2026.103297. Epub 2026 Apr 24.
- 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 principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refeeding Syndrome and Acute Abdomen, run by Jens Rikardt Andersen at 1 site in Denmark.
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 4 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 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
sodium balance (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04966780, which also lists 1 linked publication.
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 26 Jul 2021.