Heterogeneity of Critical Illness: a Cohort Study

Critically Ill Clinical Trial

— HEALICS  

Official title:

Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04502511
• Other study ID #: 202000405
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2020
• Source: University Medical Center Groningen
• Contact: Willem Dieperink, PhD
• Phone: +31 503619838
• Email: w.dieperink[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Multiple Organ Failure
• Organ Failure, Multiple

Intervention

Diagnostic Test:
• Standard diagnosis test
Care as usual

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During ICU admission with a maximum of 90 days
Secondary	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+).	6 and 12 months after ICU discharge