Circadian Melatonin Rhythms in Critically Ill Patients With Delirium

NCT04721613 | Completed

• 1 other identifier: BASEC_01_2021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Delirious patients often suffer from sleep disturbances such as insomnia, sleep fragmentation, daytime somnolence, and reversal of sleep-wake rhythms. There is evidence, that patients suffering from hyperactive, as well as hypoactive and mixed delirium suffer from disturbed circadian rhythm. The investigators hypothesize that the circadian melatonin profile in critically ill delirious patients measured at two-hourly intervals deviates significantly in terms of phase, width and amplitude from non-delirious critically ill patients with similar age and SOFA (Sequential Organ Failure Assessment) score.

Conditions

ICU Delirium

Outcome Measures

Primary Outcomes (1)

• Melatonin profile

  Difference in melatonin profile in ICU patients with delirium compared to non-delirious patients

  24 hours

Study Arms (3)

Hypoactive ICU delirium

Other: Assessment of Melatonin level

Hyperactive or mixed ICU delirium

Other: Assessment of Melatonin level

Critically ill patients not suffering form ICU delirium

Other: Assessment of Melatonin level

Interventions

Assessment of Melatonin level OTHER

Measuring the plasma or serum melatonin in pg/ml during the first 24 hours after delirium diagnosis in two-hour intervals.

Critically ill patients not suffering form ICU delirium; Hyperactive or mixed ICU delirium; Hypoactive ICU delirium

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will include 20 patients that fulfil inclusion criteria and do not complete any of the exclusion criteria. Half of the patients should suffer from a hyperactive/mixed delirium with a RASS score ≥2, the other half from a hypoactive delirium. For the control group of 10 patients, the investigators will select age-matched patients grouped in a range of ten years with a minimum of 55 years (55-64 years, 65-74 years, 75-84 years, 85-94 years and higher). The patients of both groups will be hospitalized in the ICU also meeting a similar SOFA score (difference +/- one point). Five patients of the control group will be matched with hyperactively/mixed delirious patients, the other five patients with hypoactively delirious patients.

You may qualify if:

• Adult patients (aged 55 years or older)
• Admission to the ICU
• Current delirium (ICDSC ≥4)
• Functioning venous or arterial line for blood sample collection

You may not qualify if:

• Delirium prior to ICU admission
• Premenopausal women
• Terminal state
• Dementia
• Substance abuse including alcohol in current medical history

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Centre for Chronobiology, Transfaculty Research Platform Molecular and Cognitive Neurosciences (MCN), Psychiatric Hospital of the University of Basel (UPK): collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: March 31, 2021
• Primary Completion: May 24, 2023
• Study Completion: May 25, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

CH (1)