Heterogeneity of Critical Illness in ICU Patients
Official title: Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study
Run by University Medical Center Groningen · NCT04502511 · Data updated 2026-11-12
This study tests how patient characteristics relate to the severity of organ failure in adults admitted to the ICU with critical illness.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | January 1, 2030 |
| Study ends | January 1, 2030 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT04502511 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) admitted emergently to the ICU for acute or unexpected critical illness and with an invasive arterial or venous line in place for standard care.
✕Probably not a fit
Patients who do not experience additional blood sampling or who are not followed for long-term outcomes may see no direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort study of adult critically ill patients admitted to the ICU. The researchers will examine how baseline characteristics relate to how severely organs fail during the ICU stay, using the maximum SOFA score as the primary measure and quality of life at one year as a follow-up endpoint. Data collection aligns with standard ICU care, with optional additional exams and a blood sample obtained during admission; follow-up includes phone assessments at 6 months and home visits at 12 months. No new treatments are tested or assigned; the study observes real-world practice to identify patterns and potential causal pathways behind divergent outcomes. IRB-approved procedures ensure patient safety and privacy, and informed consent is required.
Why it matters
Potential benefit: If successful, the study could improve understanding of which patients are at higher risk for severe organ failure and guide future strategies to mitigate such risk.
How similar studies have gone: Previous observational work in critical illness has identified heterogeneous organ failure trajectories, though this specific approach of linking baseline characteristics to maximum SOFA and long-term QoL is ongoing and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults Definition: age ≥18 years. * Emergency admission to the ICU Definition: patients who are acutely admitted to the ICU due to acute or unexpected critical illness, either from the emergency department or the ward or transferred from an ICU (or a ward) from another hospital. Exclusion Criteria: * Planned admission * Absence of an invasive arterial or venous line for blood sampling. * Any continued cardiopulmonary resuscitation efforts upon admission which limit access to the patient for research activities. * Main ICU admission reason chronic (non-invasive) home ventilation * Main ICU admission reason normothermic treatment after cardiac arrest * Main ICU admission reason ischemic stroke, intracerebral bleeding, or isolated neurotrauma * Main ICU admission reason Coronavirus Disease 2019 (COVID-19) * Solid organ or hematopoietic stem cell transplant during current hospital admission * Strict isolation due to any contagious disease * No informed consent
Where it's running
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University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands Recruiting
Study contacts
- Principal investigator: Frederik Keus, PhD — University Medical Center Groningen
- Study coordinator: Fredrike Zwiers, PhD
- Email: f.zwiers-blokzijl@umcg.nl
- Phone: +31 503619838
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.