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

Not Applicable

Completed

• Conditions: Critical Illness; COVID-19; Delirium
• Interventions: Combination Product: Sham HD-tDCS; Combination Product: Active HD-tDCS

• Registration Number: NCT05963958
• Lead Sponsor: Suellen Andrade

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Primary Completion: 2022-12-02
• Study Completion: 2023-01-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-01
• Study First Submitted QC: 2023-07-25
• Last Update Submitted: 2023-07-25
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham HD-tDCS	Sham HD-tDCS	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).
Active HD-tDCS	Active HD-tDCS	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Federal University of Paraiba; 🇧🇷 João Pessoa, Paraiba, Brazil