Predictors of Emergency Department Use in Frail Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Pisa
About this trial
When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. While cognitive impairment is a known clinical risk factor, biomarkers of most prevalent dementias have been scarcely investigated as possible ED use predictors. Within this context, this prospective study aims at exploring whether plasma phospho-tau181 and cerebrovascular burden can predict ED use at 6 months in elderly non-autonomous patients, irrespective of frailty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
fluency in Italian language,
age higher than 64 years,
loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires,
having performed routinary blood exams in the 6 months prior to recruitment
Disqualifiers
withdrawal of the informed consent
Trial population
Adults fulfilling the inclusion criteria consecutively recruited during their outpatient visits at the Neurology and Geriatrics Units of the Pisa University Hospital (Italy).
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Plasma phosphorylated Tau 181
Diagnostic testPlasma will be collected in dipotassium EDTA tubes at recruitment and centrifugated at 1800-2000xg for 10 minutes within a short data frame. Plasma will be subsequently aliquoted and stored at -80°C. Immediately prior to analysis, samples will be thawed at room temperature, vortexed, and centrifuged. Plasma p-tau181 concentrations will be then quantified using a fully automated chemiluminescent enzyme immunoassay on the LUMIPULSE G600II system, in accordance with the manufacturer's instructions.
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Elderly, non-autonomous Patients1 intervention
Trial outcomes
Primary outcomes
1
Emergency Department Use
The patient visits an emergency department (ED). The proportion of participants visiting the ED will be assessed at the end of the observational period. Biomarkers of cognitive impairment, i.e., plasma phosphorylated tau 181 and cerbrovascular burden, will be subsequently tested as possible predictors of this outcome.
Time frame
Within 6 months from recruitmentSecondary outcomes
1
Time to emergency department use
The difference in days between the emergency department (ED) use and the recruitment date. The mean time to emergency department use will be assessed in ED users at the end of the observational period. Biomarkers of cognitive impairment, i.e., plasma phosphorylated tau 181 and cerbrovascular burden, will be subsequently tested as possible predictors of this outcome.
Time frame
Within 6 months from recruitment.Sponsors and contacts
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University of Pisa
Lead sponsor
Azienda Ospedaliero, Universitaria Pisana
Collaborator
Source ClinicalTrials.gov