HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19

Conditions
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COVID-19, Delirium, Critical Illness

Intervention / Treatment
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* Combination Product: Active HD-tDCS
* Combination Product: Sham HD-tDCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active HD-tDCS<br>HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For each participant, a 3-mA current is applied via a center anode. The electric current was supplied to the active group and presented an acceleration time of 30 s, maintained at 3 mA for 30 min and then reduced for 30 s. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour). | Combination Product: Active HD-tDCS<br>* 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<br>|
| Placebo Comparator: Sham HD-tDCS<br>HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For the simulated condition, the investigators maintained the same 30-second acceleration up to a total of 3 mA, followed immediately by a 30-second deceleration. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour). | Combination Product: Sham HD-tDCS<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium Severity | delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in the ICU and hospital stay | defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge | 28 days | 
| Occurrence of hypotension requiring any vasopressor administration |  | 28 days | 
| C-reactive protein levels |  | 28 days | 
| ventilator-free days during the first 28 days | defined as the number of days free from mechanical ventilation for at least 48 consecutive hours | 28 days | 
| Exploratory analisys | Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis | 28 days |