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NCT Number: NCT07368062

Mental Health After Dexmedetomidine for Electrical Storm

The goal of the research study is to measure mental health and quality of life indices of individuals treated for electrical storm (ES). The consequences of being admitted to an intensive care unit (ICU) with electrical storm as well as the treatments patients would have received, are currently not well understood. Understanding the mental health burden of these treatments among survivors can provide insights into how to improve care.

This is a study consisting of patients who participated in the SEDATE trial (dexmedetomidine vs usual standard of care to treat ES in the ICU). Patients who consent to participate in this study will be asked to complete a set of questionnaires 3-6 months after their ICU admission. The purpose of the questionnaires is to measure indices of mental health and health-related quality of life. Each questionnaire will take about 5-15 minutes to complete.

If patients have a scheduled follow-up at the University of Ottawa Heart Institute, a member of the research team will meet with them during their clinic visit to complete the questionnaires. Otherwise, they can be completed over the telephone.

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Key information

Conditions

Mental Health Arrhythmias, Cardiac Behavior Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Tachycardia Tachycardia, Ventricular

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location status: Recruiting

Location contact

Francisco D Ramirez, MD MSc FRCPC

CONTACT

[email protected]

1+ 613 696 7000

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients admitted to an intensive care unit with a diagnosis of electrical storm within the preceding 6 months
  • Previous participants in the SEDATE trial (NCT06281977)

Exclusion criteria

  • None

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine infusion during ICU admission for electrical storm

Placebo

Drug

Placebo (standard of care, no dexmedetomidine), for treatment of electrical storm while admitted to ICU

Primary outcomes

  1. Post-traumatic stress disorder symptoms

    Time frame: Assessed 3-6 months after hospitalization for electrical storm

    Post-traumatic stress disorder (PTSD) checklist (PCL-5) score. Respondents are asked to rate the presence and severity of various symptoms in the preceding month on 5-point Likert scale. A higher score indicates worse symptoms. A cumulative cut-off score of 31-33 is usually considered indicative of probable PTSD

Secondary outcomes

  1. Anxiety symptoms

    Time frame: Assessed 3-6 months after hospitalization for electrical storm

    General Anxiety Disorder 7-item (GAD-7). This is a screening tool for the presence and measure of the severity of anxiety symptoms. A higher score suggests more severe symptoms

  2. Depression symptoms

    Time frame: Assessed 3-6 months after hospitalization for electrical storm

    Patient Health Questionnaire-9 (PHQ-9). This is a screening tool for the presence and measure of the severity of depression symptoms. A higher score suggests more severe symptoms.

  3. Anxiety/fear relating to implantable cardioverter-defibrillator shocks

    Time frame: Assessed 3-6 months after hospitalization for electrical storm

    Florida Shock Anxiety Scale (FSAS). This is a measure of patient anxiety/fear relating to implantable cardioverter-defibrillator shocks. A higher score suggests more shock-related anxiety

  4. Quality of life measure

    Time frame: Assessed 3-6 months after hospitalization for electrical storm

    Quality of life measurements, as obtained through use of the 36-Item Short Form Survey Instrument (SF-36), a validated questionnaire tool to measure health-related quality of life/health status across specific domains. A higher score indicates better self-reported health

Study contacts

Contact information is provided by the study sponsor or research team.

F Daniel Ramirez, MD MSc FRCPC

CONTACT

[email protected]

1+ 613-696-7000

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm: Outpatient Follow-up of Mental Health INDices (SDATE OF MIND)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 26, 2026
Registry last updated
Jul 1, 2026

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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