Status:
COMPLETED
The EARLY DELTA Trial
Lead Sponsor:
Thomas Ottens
Collaborating Sponsors:
Prolira
Dutch Society of Intensive Care
Conditions:
Delirium
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Delirium is a type of acute encephalopathy that is triggered by an underlying somatic disorder. Patients experience disturbances in attention, alertness and other cognitive functions. In pa...
Eligibility Criteria
Inclusion
- Adult (18 years or above) admitted to ICU for any indication
- ICU length of stay anticipated to be 48h or longer from time of screening for inclusion
- Written informed consent by patient or representative
Exclusion
- More than 48 hours have elapsed since the patient was first eligible to undergo a DeltaScan measurement after ICU admission. A patient is eligible for DeltaScan measurements if they are a. able to cooperate with simple instructions AND b. are alert or mildly sedated no deeper than a Richmond Agitation and Sedation Score of -2.
- Admission for out-of-hospital cardiac arrest, status epilepticus, hemorrhagic or ischemic stroke, increased intracranial pressure, head trauma
- Recent intracranial neurosurgery (\<30 days prior to inclusion)
- Known space-occupying lesions in the brain or skull
- Metal implants in brain or skull
- Diagnosis of dementia or Parkinson's disease
- Inpatient from nursing home
- Lithium use (\<30 days prior to inclusion)
- Imminent death or palliative care phase
- Patients ánd their legal representatives both do not understand Dutch or English
- Patients who participated in the EARLY DELTRA trial \<90 days ago
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2025
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT05403268
Start Date
March 2 2022
End Date
August 19 2025
Last Update
August 24 2025
Active Locations (2)
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1
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7512 KZ
2
HagaZiekenhuis
The Hague, South Holland, Netherlands, 2545 AA