Heterogeneity of Critical Illness: a Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard diagnosis test.
- Who it may be relevant to
- Registry conditions: Critically Ill, Organ Failure, Multiple. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study
Overview
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
Detailed description
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: \<All patients will undergo physical examination, including ultrasound evaluation upon ICU admission according to standard practice care. The burden will be a blood sample (and urine sample) at admission. Blood sample will be obtained by arterial line (or venous access) which is part of standard ICU care. So there will be no additional puncture for this study. Collection of variables during ICU stay will all be either part of standard clinical care or include extra physical examination or ultrasound evaluation. For follow-up patients will be evaluated by phone at 6 months and at 12 months by home-visit. This is also already part of the investigator's evaluation of quality of care. Except for blood sampling, all study related procedures have previously been approved by the Institutional Review Board (IRB). The patient will experience no individual benefit.
Interventions
- Diagnostic test Standard diagnosis test
Care as usual
Primary outcome measures
- Severity of organ failure observed during ICU stay [Time frame: During ICU admission with a maximum of 90 days]
Secondary outcome measures (1)
- Follow-up Quality of life data [Time frame: 6 and 12 months after ICU discharge]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Publications
- 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. PMID 40906653
Identifiers
NCT: NCT04502511 · 202000405