Clinical trial NCT04502511: Heterogeneity of Critical Illness: a Cohort Study
Official title: Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Organ Failure, Multiple
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients acutely admitted to the ICU

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

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.

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

Primary outcomes:
measure: Severity of organ failure observed during ICU stay
timeFrame: During ICU admission with a maximum of 90 days
Secondary outcomes:
measure: Follow-up Quality of life data
timeFrame: 6 and 12 months after ICU discharge
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Groningen
name: Frederik Keus, PhD
role: PRINCIPAL_INVESTIGATOR
References: