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Completed

NCT Number: NCT05963958

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

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.

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Key information

Conditions

COVID-19 Confusion Coronaviridae Infections Coronavirus Infections Critical Illness Delirium Disease Attributes Infections Lung Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Paraiba

João Pessoa, Paraíba, 51051900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active HD-tDCS

Combination Product

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

Combination Product

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 outcomes

  1. Delirium Severity

    Time frame: 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 outcomes

  1. length of stay in the ICU and hospital stay

    Time frame: 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

  2. Occurrence of hypotension requiring any vasopressor administration

    Time frame: 28 days

  3. C-reactive protein levels

    Time frame: 28 days

  4. ventilator-free days during the first 28 days

    Time frame: 28 days

    defined as the number of days free from mechanical ventilation for at least 48 consecutive hours

  5. Exploratory analisys

    Time frame: 28 days

    Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis

Sponsors and collaborators

Lead sponsor

Suellen Andrade

Other

Collaborators

  • City University of New York

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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