Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06344546
• Other study ID #: K 2023-10247
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Karolinska University Hospital
• Contact: Martin Sundström Rehal, MD PhD
• Phone: +46-8-12381507
• Email: martin.sundstrom[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Critical Illness
• Hypophosphatemia
• Refeeding Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Metabolomics
Analysis of the metabolome in plasma samples.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Countries where clinical trial is conducted

Czechia,  Italy,  Sweden, 

Outcome

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.