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NCT Number: NCT04502511

Heterogeneity of Critical Illness: a Cohort Study

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location status: Recruiting

Location contact

Fredrike Zwiers, PhD

CONTACT

[email protected]

0503619838

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard diagnosis test

Diagnostic Test

Care as usual

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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+).

Study contacts

Contact information is provided by the study sponsor or research team.

Fredrike Zwiers, PhD

CONTACT

[email protected]

+31 503619838

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: HEALICS

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Aug 6, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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