NCT04502511 Heterogeneity of Critical Illness: a Cohort Study
| NCT ID | NCT04502511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Critically Ill |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2022-01-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frederik Keus, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT04502511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critically Ill. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04502511 currently recruiting?
Yes, NCT04502511 is actively recruiting participants. Contact the research team at f.zwiers-blokzijl@umcg.nl for enrollment information.
Where is the NCT04502511 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT04502511 clinical trial?
NCT04502511 is sponsored by University Medical Center Groningen. The principal investigator is Frederik Keus, PhD at University Medical Center Groningen. The trial plans to enroll 5,000 participants.