Heterogeneity of Critical Illness: a Cohort Study (HEALICS)
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|ClinicalTrials.gov Identifier: NCT04502511|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
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
|Condition or disease||Intervention/treatment|
|Critically Ill Organ Failure, Multiple||Diagnostic Test: Standard diagnosis test|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
Adult critically ill patients in the ICU
Acutely admitted to the ICU
Diagnostic Test: Standard diagnosis test
Care as usual
- Severity of organ failure observed during ICU stay [ 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.
- Follow-up Quality of life data [ 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.
- 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+).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502511
|Contact: Willem Dieperink, PhD||+31 firstname.lastname@example.org|
|Principal Investigator:||Frederik Keus, PhD||University Medical Center Groningen|