COVID-19, Critical Illness, Delirium
Conditions
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.
Interventions
COMBINATION_PRODUCTActive HD-tDCS
Brain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
COMBINATION_PRODUCTSham HD-tDCS
Sham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
Sponsors
City University of New York
Suellen Andrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| length of stay in the ICU and hospital stay | 28 days | defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge |
| Occurrence of hypotension requiring any vasopressor administration | 28 days | — |
| C-reactive protein levels | 28 days | — |
| ventilator-free days during the first 28 days | 28 days | defined as the number of days free from mechanical ventilation for at least 48 consecutive hours |
| Exploratory analisys | 28 days | Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis |
Countries
Brazil
Outcome results
None listed