Critical Illness Clinical Trial
Official title:
Metabolic Pathway Analysis in Refeeding Syndrome: a Nested Explorative Metabolomics Substudy of the GUTPHOS Multicenter Observational Study (GUTPHOS-Metabolomics)
NCT number | NCT06344546 |
Other study ID # | K 2023-10247 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2024 |
Est. completion date | June 2024 |
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Admission to ICU during the study period - Age =18 years Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Královské Vinohrady | Prague | |
Italy | University Hospital Policlinico of Foggia | Foggia | |
Sweden | Karolinska University Hospital | Huddinge | Stockholm |
Sweden | Karolinska Universitetssjukhuset Solna | Stockholm | |
Sweden | Södersjukhuset | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital |
Czechia, Italy, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Onset of RFS, within the first 7 days in ICU. | |
Secondary | 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. | Prior to onset of RFS, within the first 7 days in ICU. |
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