An observational study in Critical Illness, Refeeding Syndrome and Hypophosphatemia, sponsored by Karolinska University Hospital. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Karolinska University Hospital · Observational
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.
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.
24 studies on the registry are indexed under Refeeding Syndrome; 7 are open to participants now.
This study's enrollment of 218 is above the median of 57 across 16 observational studies indexed under Refeeding Syndrome.
Browse Refeeding Syndrome studies →Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.
Compared within Refeeding Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients admitted to the intensive care unit.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ICU patients who fulfill diagnostic criteria for refeeding hypophosphatemia.
Diagnostic Test: Metabolomics
ICU patients without refeeding hypophosphatemia. Controls selected to match for sex, age, severity of illness and nutritional delivery prior to refeeding hypophosphatemia.
Diagnostic Test: Metabolomics
Analysis of the metabolome in plasma samples.
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.
Time frame: Onset of RFS, within the first 7 days in ICU.
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.
Time frame: Prior to onset of RFS, within the first 7 days in ICU.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Jun 2024, 2 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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