Actively Recruiting

Age: 18Years +
All Genders
ID04502511

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

Led by University Medical Center Groningen · Updated on 2026-05-26

5000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying critically ill adult patients admitted to the Intensive Care Unit (ICU) to understand the diverse disease states and severity patterns during their ICU stay. The study aims to explore how patient characteristics relate to the severity of organ failure, measured by the maximum SOFA score, and to assess quality of life one year after ICU discharge. This observational cohort study addresses gaps in understanding the causes behind different outcomes among critically ill patients and seeks common pathways across various diseases. Participants in this study will undergo standard diagnostic tests and care upon ICU admission, including physical examinations and ultrasound evaluations. Blood and urine samples will be collected at admission using existing arterial or venous lines to avoid extra procedures. The study includes follow-up evaluations by phone at six months and home visits at twelve months after ICU discharge to assess quality of life, with no additional burdens beyond standard care practices. Throughout the study, data will be collected during the ICU stay, with a maximum observation period of 90 days to monitor organ failure severity. Follow-up assessments at six and twelve months will measure patient quality of life. Most procedures align with routine clinical care, minimizing extra interventions. The study involves no direct treatment changes and focuses on collecting information to better understand risks and outcomes in the ICU setting over several years.

CONDITIONS

Brief Title

Heterogeneity of Critical Illness: a Cohort Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Emergency admission to the ICU due to acute or unexpected critical illness
  • Admission may be from emergency department, ward, or transfer from another ICU or hospital
Not Eligible

You will not qualify if you...

  • Planned ICU admission
  • No invasive arterial or venous line available for blood sampling
  • Ongoing cardiopulmonary resuscitation efforts limiting research access
  • Main ICU admission for chronic non-invasive home ventilation
  • Main ICU admission for normothermic treatment after cardiac arrest
  • Main ICU admission for ischemic stroke, intracerebral bleeding, or isolated neurotrauma
  • Main ICU admission due to COVID-19
  • Solid organ or hematopoietic stem cell transplant during current hospital stay
  • Strict isolation because of contagious disease
  • Lack of informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment occur at ICU admission.

Diagnostic Evaluation

Duration - Up to 90 days during ICU stay

Participants undergo physical examination including ultrasound evaluation and blood and urine sampling at ICU admission as part of standard care.

Assessments during ICU stay as part of routine clinical care with no additional punctures.

Long-term Monitoring

Duration - 6 and 12 months after ICU discharge

Participants are evaluated for quality of life during follow-up after ICU discharge.

1 phone visit at 6 months and 1 home visit at 12 months post-discharge.

Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands, 9713GZ

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Research Team

F

Fredrike Zwiers, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Validation of plasma microRNAs as biomarkers in sepsis associated acute kidney injury upon first clinical presentation reveals limited diagnostic and prognostic performance.

Tamar J van der Aart, Matthijs Luxen, Jacqueline Koeze...

https://pubmed.ncbi.nlm.nih.gov/40906653