Digital and Plasma Biomarkers in Delirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorScripps Health
About this trial
The goal of this observational study is to learn if there are potential digital and plasma-based biomarkers that could help detect, predict, and prognosticate delirium in older adult patients who are admitted to the intensive care unit (ICU). The main question DELTA aims to answer is:
Can digital biometrics predict and detect delirium in older adult ICU patients? Do biomarkers of neurodegeneration fluctuate in ICU patients in such a way that delrium could potentially be predicted?
Participants admitted o the ICU will wear a digital device to collect biometric data and will have serial plasma samples collected during ICU admission and patients will be also assessed for delirium daily by study staff.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to the intensive care unit
Able to consent or have a legally authorized representative consent on their behalf
English speaker
Expected ICU stay of 48 hours or more
Disqualifiers
Advanced dementia
End stage liver disease
Renal replacement therapy
Structural brain injury, including but not limited to traumatic brain injury, cerebrovascular accident and intracranial hemorrhage,
Trial population
Critically ill older adults.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: DELTA Cohort
Trial outcomes
Primary outcomes
1
Delirium
Delirium incidence as assessed by the CAM-ICU instrument.
Time frame
Between enrollment and ICU discharge, up to a maximum of 10 days.Secondary outcomes
1
Sleep Duration
Daily total sleep duration as measured by actigraphy
Time frame
Between enrollment and ICU discharge up to a maximum 10 days in the ICU.2
Sleep fragmentation
Nightly sleep fragmentation as measured by actigraphy
Time frame
Nightly between enrollment and ICU discharge, up to a maximum of 10 days.3
Circadian activity rhythm disruption
Using daily activity/temperature/heart rate, circadian activity rhythms will be assessed for goodness of fit to a cosinor curve.
Time frame
Daily between enrollment and ICU discharge, up to a maximum of 10 days.Other outcomes
1
Delirium duration
As measured by CAM-ICU
Time frame
between enrollment and ICU discharge up to a maximum of 10 daysSponsors and contacts
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Source ClinicalTrials.gov