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ACTIVE NOT RECRUITING
NCT07811492

CIRCA-MED WP1 & WP3 - Circadian Rhythms in ICU Patients

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

Summary

The goal of this retrospective exploratory study is to examine how the body's natural day-and-night rhythms and oscillatory patterns behave in people who were treated in the Intensive Care Unit (ICU). The study uses routine clinical data that were already collected during and after the ICU stay, including post-discharge follow-up measurements (where available), such as heart rate, temperature, blood pressure, blood sugar, and insulin. The researchers want to learn whether these measurements show daily patterns and whether patients can be grouped based on their oscillatory profiles. The study also examines whether certain clinical factors such as illness severity scores, sedation levels, organ support treatments, or medications are associated with changes in these oscillatory rhythms. The team will explore whether conditions that can develop during or after critical illness, such as delirium, muscle weakness, or Post-Intensive Care Syndrome (PICS), are linked to disturbed physiological rhythms. Another goal is to test whether it is technically possible to show a patient's rhythm profile in real time using routine data from the ICU information system, evaluated retrospectively. Digital tools called "Chrono-Apps" will be developed to display rhythmic information and may help clinicians adjust lighting to patient needs.

Official title: Retrospective Characterization of Circadian Rhythms Using Vital Signs and Other Routine Data From Patients in the Intensive Care Unit

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

25000

Start Date

2025-10-01

Completion Date

2029-09-30

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

OTHER

Exposure to routine clinical parameters

These are the primary exposures and are used to detect oscillatory patterns and characterize circadian rhythms. They include heart rate, body temperature, blood pressure, blood glucose, and insulin.

OTHER

Exposure to ICU clinical factors and treatments

These are secondary exposures that may influence circadian rhythms: illness severity (e.g., Sequential Organ Failure Assessment (SOFA) score), sedation levels, organ support therapies (e.g., ventilation, dialysis, Extracorporeal Membrane Oxygenation (ECMO)), and medications administered during ICU stay (e.g., sedatives, vasopressors, corticosteroids).

OTHER

Exposure to critical illness-related conditions

These exposures represent complications that may be associated with circadian disruption: delirium, deep sedation, ICU-acquired muscle weakness, and post-intensive care syndrome.

OTHER

Exposure to molecular and hormonal circadian markers

These exposures reflect biological clock function: clock gene expression (if available in some cases), and melatonin levels.

OTHER

Exposure to metabolic changes related to critical illness

These exposures represent metabolic consequences of critical illness: insulin sensitivity, muscle atrophy, and critical illness myopathy or ICU-acquired weakness.

Locations (1)

Institute of Medical Informatics, Charite University, Berlin

Berlin, Germany