Heterogeneity of Critical Illness: a Cohort Study

NCT04502511 | Unknown

• 1 other identifier: 202000405
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Critically Ill; Organ Failure, Multiple

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Follow-up Quality of life data

  6 and 12 months after ICU discharge

Study Arms (1)

Adult critically ill patients in the ICU

Acutely admitted to the ICU

Diagnostic Test: Standard diagnosis test

Interventions

Standard diagnosis test DIAGNOSTIC_TEST

Care as usual

Adult critically ill patients in the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients acutely admitted to the ICU

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Related Publications (1)

• van der Aart TJ, Luxen M, Koeze J, Londen MV, Hackl M, Ter Maaten JC, van Meurs M, Bouma HR; the Acutelines research group. Validation of plasma microRNAs as biomarkers in sepsis associated acute kidney injury upon first clinical presentation reveals limited diagnostic and prognostic performance. PLoS One. 2025 Sep 4;20(9):e0331442. doi: 10.1371/journal.pone.0331442. eCollection 2025.

  PMID: 40906653 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Critical Illness; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Frederik Keus, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Willem Dieperink, PhD

CONTACT

+31 503619838; w.dieperink@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 6, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: In two years
• Access Criteria: On request