Heterogeneity of Critical Illness: a Cohort Study (HEALICS)

University Medical Center Groningen (UMCG)

Status

Unknown

Conditions

Critically Ill

Organ Failure, Multiple

Treatments

Diagnostic Test: Standard diagnosis test

Study type

Observational

Funder types

Other

Identifiers

NCT04502511

202000405

Details and patient eligibility

About

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

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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