Critical IllnessNCT06344546
Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome
An observational study of Critical Illness and Refeeding Syndrome, run by Karolinska University Hospital at 4 sites in 3 countries.
Trial summary
The overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Refeeding Syndrome, Hypophosphatemia
- What is being tested?
- Metabolomics
- How many people
- 218 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Apr 2024to 2 Jun 2024
- 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: Patients admitted to the intensive care unit.
Who may be able to join
- Admission to ICU during the study period
- Age ≥18 years
Who cannot join
- Age <18 years
- Patients with restrictions of care such as "no intubation" or "no renal replacement therapy" on ICU admission and patients admitted for treatment as organ donors
- Continuous chronic home ventilation for neuromuscular disease;
- Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study);
- Readmission to ICU during the study period
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Sweden2 sites
Karolinska University Hospital
Huddinge, Stockholm County, 14186
Karolinska Universitetssjukhuset Solna
Stockholm
About this study
Official title: Metabolic Pathway Analysis in Refeeding Syndrome: a Nested Explorative Metabolomics Substudy of the GUTPHOS Multicenter Observational Study (GUTPHOS-Metabolomics)
The overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Blood samples are collected day 1-7 of ICU stay. Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. Untargeted analyses will be performed to identify the affected metabolic pathways. The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS.
Read the detailed description
A nested case-control study situated within GUTPHOS Part B: A prospective, multicenter non-interventional cohort study investigating the incidence of abnormal phosphate levels and associated outcomes in adult patients admitted to the ICUs of participating sites. Inclusion/exclusion criteria for GUTPHOS Part B are described in the separate study protocol.
At sites participating in the nested substudy, an additional 2 ml EDTA blood sample is drawn once daily in all patients included in GUTPHOS Part B from ICU admission up to a maximum of calendar day 7 in ICU. The sampling for metabolomics analysis should be performed in close proximity with daily routine blood tests, and always before treatment of hypophosphatemia with phosphate supplementation or restricted nutritional intake. Plasma samples are obtained through centrifugation within 20 minutes and frozen to -80 degrees Celcius within 60 minutes until analysis. The timing and handling of samples according to standard operating procedures will be documented on a separate case report form.
In ICU patients diagnosed with refeeding hypophosphatemia, comprehensive metabolomic profiling is performed in the plasma sample from ICU admission and the sample drawn in conjunction to the blood phosphate measurement diagnostic of RH.
Cases with RH are matched in a 1:1 ratio to ICU patients without RH. Controls are matched according to sex, age, illness severity on admission and energy delivery (kcal/kg adjusted body weight) in the 24 hours preceding the diagnosis of RH.
Refeeding hypophosphatemia is defined as new onset hypophosphatemia (<0.65 mmol/L) within 72 hours from the start of medical nutrition therapy, with a drop of >0.16 mmol/L from any previous Pi value during ICU stay and where no other likely cause of hypophosphatemia is present.
- Conditions
- Critical Illness, Refeeding Syndrome, Hypophosphatemia
- Being tested
- Metabolomics
- Medical subject headings
- Critical Illness, Refeeding Syndrome, Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetabolomicsDiagnostic test
Analysis of the metabolome in plasma samples.
| Study group | Role | What they receive |
|---|---|---|
| Refeeding hypophosphatemia | ICU patients who fulfill diagnostic criteria for refeeding hypophosphatemia. Receives: Diagnostic Test: Metabolomics | |
| Controls | ICU patients without refeeding hypophosphatemia. Controls selected to match for sex, age, severity of illness and nutritional delivery prior to refeeding hypophosphatemia. Receives: Diagnostic Test: Metabolomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics
The plasma metabolome (>300 metabolites related to cell metabolism) will be characterized by mass spectroscopy from blood samples taken at the onset of refeeding syndrome (RFS) and analyzed for specific alterations in metabolic pathways associated with RFS in an untargeted approach.
Measured: Onset of RFS, within the first 7 days in ICU.
Secondary outcomes (1)
Metabolomics
Potential biomarkers in the plasma metabolome (>300 metabolites related to cell metabolism) associated with the development of refeeding syndrome (RFS) will be identified through principal component analysis and ROC curve analysis.
Measured: Prior to onset of RFS, within the first 7 days in ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Apr 2024
- Primary completion2 Jun 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Foggia Hospital, Faculty Hospital Kralovske Vinohrady
- Responsible party
- Principal investigator, Martin Sundstrom Rehal, Karolinska University Hospital
- Investigators
- Olav Rooyackers, PhD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344546
- Sponsor's protocol ID
- K 2023-10247
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Pathway Analysis in Refeeding Syndrome: a Nested Explorative Metabolomics Substudy of the GUTPHOS Multicenter Observational Study (GUTPHOS-Metabolomics)
- ClinicalTrials.gov ID
- NCT06344546
- Acronym / sponsor ID
- K 2023-10247
- Conditions
- Critical Illness, Refeeding Syndrome, Hypophosphatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Foggia Hospital, Faculty Hospital Kralovske Vinohrady
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 3 Apr 2024 (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 overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Blood samples are collected day 1-7 of ICU stay. Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. Untargeted analyses will be performed to identify the affected metabolic pathways. The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS.
Detailed description
A nested case-control study situated within GUTPHOS Part B: A prospective, multicenter non-interventional cohort study investigating the incidence of abnormal phosphate levels and associated outcomes in adult patients admitted to the ICUs of participating sites. Inclusion/exclusion criteria for GUTPHOS Part B are described in the separate study protocol.
At sites participating in the nested substudy, an additional 2 ml EDTA blood sample is drawn once daily in all patients included in GUTPHOS Part B from ICU admission up to a maximum of calendar day 7 in ICU. The sampling for metabolomics analysis should be performed in close proximity with daily routine blood tests, and always before treatment of hypophosphatemia with phosphate supplementation or restricted nutritional intake. Plasma samples are obtained through centrifugation within 20 minutes and frozen to -80 degrees Celcius within 60 minutes until analysis. The timing and handling of samples according to standard operating procedures will be documented on a separate case report form.
In ICU patients diagnosed with refeeding hypophosphatemia, comprehensive metabolomic profiling is performed in the plasma sample from ICU admission and the sample drawn in conjunction to the blood phosphate measurement diagnostic of RH.
Cases with RH are matched in a 1:1 ratio to ICU patients without RH. Controls are matched according to sex, age, illness severity on admission and energy delivery (kcal/kg adjusted body weight) in the 24 hours preceding the diagnosis of RH.
Refeeding hypophosphatemia is defined as new onset hypophosphatemia (<0.65 mmol/L) within 72 hours from the start of medical nutrition therapy, with a drop of >0.16 mmol/L from any previous Pi value during ICU stay and where no other likely cause of hypophosphatemia is present.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refeeding hypophosphatemia | – | Diagnostic Test: MetabolomicsICU patients who fulfill diagnostic criteria for refeeding hypophosphatemia. |
| Controls | – | Diagnostic Test: MetabolomicsICU patients without refeeding hypophosphatemia. Controls selected to match for sex, age, severity of illness and nutritional delivery prior to refeeding hypophosphatemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit.
Key inclusion criteria (2 listed)
- Admission to ICU during the study period
- Age ≥18 years
Key exclusion criteria (5 listed)
- Age <18 years
- Patients with restrictions of care such as "no intubation" or "no renal replacement therapy" on ICU admission and patients admitted for treatment as organ donors
- Continuous chronic home ventilation for neuromuscular disease;
- Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study);
- Readmission to ICU during the study period
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 |
|---|---|---|
| MetabolomicsAnalysis of the metabolome in plasma samples. | Diagnostic test | Controls, Refeeding hypophosphatemia |
Primary outcome
Metabolomics
Time frame: Onset of RFS, within the first 7 days in ICU.
The plasma metabolome (>300 metabolites related to cell metabolism) will be characterized by mass spectroscopy from blood samples taken at the onset of refeeding syndrome (RFS) and analyzed for specific alterations in metabolic pathways associated with RFS in an untargeted approach.
1 secondary outcome
Metabolomics
Time frame: Prior to onset of RFS, within the first 7 days in ICU.
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 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Olav Rooyackers, PhD study chair
Karolinska University Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Refeeding Syndrome, run by Karolinska University Hospital at 4 sites in 3 countries.
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 2 inclusion and 5 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Czechia, Italy. 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?
Metabolomics (time frame: Onset of RFS, within the first 7 days in ICU.). 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 2 Apr 2025.