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

COVID-19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05963958
• Other study ID #: Delirium/HD-tDCS
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: July 2023
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2023
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Critical Illness
• Delirium

Intervention

Combination Product:
• Active 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
• Sham 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

Locations

Country	Name	City	State
Brazil	Federal University of Paraiba	João Pessoa	Paraiba

Sponsors (2)

Lead Sponsor	Collaborator
Suellen Andrade	City University of New York

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Occurrence of hypotension requiring any vasopressor administration		28 days
Secondary	C-reactive protein levels		28 days
Secondary	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
Secondary	Exploratory analisys	Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis	28 days