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Rationale: There is large heterogeneity in disease states of critically ill patients at ICU admittance and there is also large heterogeneity in their disease severity during ICU stay. Still, some patients may show remarkable similarities in disease patterns. There is a lack of understanding of causal mechanisms that lead to divergent outcomes in critically ill patients, and at the same time different diseases may share common underlying, yet unidentified, causal pathways that could explain similarities between different diseases.
Objective: To explore the association between patient characteristics and the severity of organ failure in critically ill patients admitted to the ICU Study design: Prospective cohort study Study population: Adult critically ill patients in the ICU Intervention (if applicable): not applicable Main study parameters/endpoints: Maximum severity of organ failure observed during ICU stay measured by the maximum SOFA score and quality of life at one year follow-up
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult critically ill patients in the ICU | Acutely admitted to the ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard diagnosis test | Diagnostic Test | Care as usual |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of organ failure observed during ICU stay | The primary prognostic outcome will be the maximum SOFA score during ICU stay. The daily maximum SOFA score will be considered up to a maximum of 90 days. | During ICU admission with a maximum of 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up Quality of life data | Patients will be evaluated by questionnaires at 6 and 12 months follow-up.Follow-up data will include survival status and data on quality of life.
In addition we will explore and validate extended modifications on the total and domain level of the organ failure assessment score (SOFA+). |
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Inclusion Criteria:
Exclusion Criteria:
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All patients acutely admitted to the ICU
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fredrike Zwiers, PhD | Contact | +31 503619838 | f.zwiers-blokzijl@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Frederik Keus, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | Provincie Groningen | 9713GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40906653 | Derived | van der Aart TJ, Luxen M, Koeze J, Londen MV, Hackl M, Ter Maaten JC, van Meurs M, Bouma HR; the Acutelines research group. Validation of plasma microRNAs as biomarkers in sepsis associated acute kidney injury upon first clinical presentation reveals limited diagnostic and prognostic performance. PLoS One. 2025 Sep 4;20(9):e0331442. doi: 10.1371/journal.pone.0331442. eCollection 2025. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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Blood samples, urine samples, microbiology samples
| 6 and 12 months after ICU discharge |