HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Delirium Severity
Study Overview
Brief Summary
The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS combined with concomitant dexmedetomidine would reduce delirium rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Applicators were blinded to who was receiving active stimulation and who was receiving placebo. The study drug was prepared by the nurses or nursing technicians, or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥18 years,
- •confirmed clinical diagnosis for SARS-CoV-2,
- •delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators
Exclusion Criteria
- •severe psychiatric illness that is not well controlled;
- •pregnancy or active lactation,
- •refusal of consent
- •contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy, dermatitis at the site of stimulation
Outcomes
Primary Outcomes
Delirium Severity
Time Frame: 28 days
delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.
Secondary Outcomes
- C-reactive protein levels(28 days)
- ventilator-free days during the first 28 days(28 days)
- Exploratory analisys(28 days)
- length of stay in the ICU and hospital stay(28 days)
- Occurrence of hypotension requiring any vasopressor administration(28 days)
Investigators
Suellen Andrade
Principal Investigator
Federal University of Paraíba