Heterogeneity of Critical Illness: a Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
All patients acutely admitted to the ICU
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard diagnosis test
Diagnostic testCare as usual
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Adult critically ill patients in the ICU1 intervention
Trial outcomes
Primary outcomes
1
Severity of organ failure observed during ICU stay
The primary prognostic outcome will be the maximum SOFA score during ICU stay. The daily maximum SOFA score will be considered up to a maximum of 90 days.
Time frame
During ICU admission with a maximum of 90 daysSecondary outcomes
1
Follow-up Quality of life data
Patients will be evaluated by questionnaires at 6 and 12 months follow-up.Follow-up data will include survival status and data on quality of life. * Patients psychological functioning will be evaluated using the Short Form 20 and the Hospital Anxiety and Depression Scale (HADS). * Patients physical functioning data will be measured by the KATZ ADL index and the Clinical Frailty Score. In addition, the Euro-Qol (EQ-5d) will be used. * Social functioning data will be collected using the General Functioning 6 scale (GF6) which is a subscale of the GF12 and is a quick and effective tool to assess the overall functioning of families. Data will be collected from both patients and family members. Return to work will only be evaluated at 12 months follow-up by 4 extra questions concerning the patients return to work. In addition we will explore and validate extended modifications on the total and domain level of the organ failure assessment score (SOFA+).
Time frame
6 and 12 months after ICU dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov