Back to resultsHD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19 (COVID-19)
Primary Purpose
COVID-19, Delirium, Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active HD-tDCS
Sham HD-tDCS
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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
Sites / Locations
- Federal University of Paraiba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active HD-tDCS
Sham HD-tDCS
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Occurrence of hypotension requiring any vasopressor administration
C-reactive protein levels
ventilator-free days during the first 28 days
defined as the number of days free from mechanical ventilation for at least 48 consecutive hours
Exploratory analisys
Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis
Full Information
NCT ID
NCT05963958
First Posted
July 1, 2023
Last Updated
July 25, 2023
Sponsor
Suellen Andrade
Collaborators
City University of New York
1. Study Identification
Unique Protocol Identification Number
NCT05963958
Brief Title
HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19
Acronym
COVID-19
Official Title
HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Suellen Andrade
Collaborators
City University of New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Delirium, Critical Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active HD-tDCS
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham HD-tDCS
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Combination Product
Intervention Name(s)
Active HD-tDCS
Intervention Description
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
Intervention Type
Combination Product
Intervention Name(s)
Sham HD-tDCS
Intervention Description
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
Primary Outcome Measure Information:
Title
Delirium Severity
Description
delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
length of stay in the ICU and hospital stay
Description
defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge
Time Frame
28 days
Title
Occurrence of hypotension requiring any vasopressor administration
Time Frame
28 days
Title
C-reactive protein levels
Time Frame
28 days
Title
ventilator-free days during the first 28 days
Description
defined as the number of days free from mechanical ventilation for at least 48 consecutive hours
Time Frame
28 days
Title
Exploratory analisys
Description
Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Federal University of Paraiba
City
João Pessoa
State/Province
Paraiba
ZIP/Postal Code
51051900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19
We'll reach out to this number within 24 hrs