Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome

NCT06344546 | Completed

• 1 other identifier: K 2023-10247
• Study Type: observational
• Target: 218
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Critical Illness; Refeeding Syndrome; Hypophosphatemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Metabolomics

  Prior to onset of RFS, within the first 7 days in ICU.

Study Arms (2)

Refeeding hypophosphatemia

ICU patients who fulfill diagnostic criteria for refeeding hypophosphatemia.

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.

Diagnostic Test: Metabolomics

Interventions

Metabolomics DIAGNOSTIC_TEST

Analysis of the metabolome in plasma samples.

Controls; Refeeding hypophosphatemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the intensive care unit.

You may qualify if:

• Admission to ICU during the study period
• Age ≥18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Foggia Hospital: collaborator
• Faculty Hospital Kralovske Vinohrady: collaborator

Study Sites (4)

University Hospital Královské Vinohrady

Prague, Czechia

Location

University Hospital Policlinico of Foggia

Foggia, Italy

Location

Karolinska University Hospital

Huddinge, Stockholm County, 14186, Sweden

Location

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (2 ml daily for first 7 days in ICU).

MeSH Terms

Conditions

Critical Illness; Refeeding Syndrome; Hypophosphatemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Phosphorus Metabolism Disorders; Metabolic Diseases

Study Officials

• Olav Rooyackers, PhD

  Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

SE (2); CZ (1); IT (1)