University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ, Netherlands
Location status: Recruiting
NCT Number: NCT04502511
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Groningen, Provincie Groningen, 9713GZ, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Care as usual
Time frame: During ICU admission with a maximum of 90 days
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: 6 and 12 months after ICU discharge
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.
In addition we will explore and validate extended modifications on the total and domain level of the organ failure assessment score (SOFA+).
Contact information is provided by the study sponsor or research team.
University Medical Center Groningen
Other
Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study
Acronym: HEALICS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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