Digital and Plasma Biomarkers in Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critical Illness, Delirium in the Intensive Care Unit, Sleep Quality. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Delirium Evaluation With Longitudinal Tau Assessment
Overview
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.
Primary outcome measures
- Delirium [Time frame: Between enrollment and ICU discharge, up to a maximum of 10 days.]
Secondary outcome measures (3)
- Sleep Duration [Time frame: Between enrollment and ICU discharge up to a maximum 10 days in the ICU.]
- Sleep fragmentation [Time frame: Nightly between enrollment and ICU discharge, up to a maximum of 10 days.]
- Circadian activity rhythm disruption [Time frame: Daily between enrollment and ICU discharge, up to a maximum of 10 days.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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,
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Scripps Green Hospital — La Jolla
- Scripps Memorial La Jolla Hospital — San Diego
Identifiers
NCT: NCT07694206 · IRB-25-8641