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Heterogeneity of Critical Illness: a Cohort Study (HEALICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502511
Recruitment Status : Not yet recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Frederik Keus, University Medical Center Groningen

Brief 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


Condition or disease Intervention/treatment
Critically Ill Organ Failure, Multiple Diagnostic Test: Standard diagnosis test

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Adult critically ill patients in the ICU
Acutely admitted to the ICU
Diagnostic Test: Standard diagnosis test
Care as usual




Primary Outcome Measures :
  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 Outcome Measures :
  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+).



Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients acutely admitted to the ICU
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Willem Dieperink, PhD +31 503619838 w.dieperink@umcg.nl

Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Frederik Keus, PhD University Medical Center Groningen
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Responsible Party: Frederik Keus, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04502511    
Other Study ID Numbers: 202000405
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On request
Supporting Materials: Study Protocol
Time Frame: In two years
Access Criteria: On request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Multiple Organ Failure
Disease Attributes
Pathologic Processes
Shock