Mental Health After Dexmedetomidine for Electrical Storm

NCT07368062 | Recruiting

• 1 other identifier: 20250008-01H
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health

Keywords

Electrical storm; Ventricular tachycardia; Dexmedetomidine; Mental health

Outcome Measures

Primary Outcomes (1)

• Post-traumatic stress disorder symptoms

  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

  Assessed 3-6 months after hospitalization for electrical storm

Secondary Outcomes (4)

• Anxiety symptoms

  Assessed 3-6 months after hospitalization for electrical storm

• Depression symptoms

  Assessed 3-6 months after hospitalization for electrical storm

• Anxiety/fear relating to implantable cardioverter-defibrillator shocks

  Assessed 3-6 months after hospitalization for electrical storm

• Quality of life measure

  Assessed 3-6 months after hospitalization for electrical storm

Study Arms (2)

Dexmedetomidine

Treatment with dexmedetomidine during electrical storm admission

Drug: Dexmedetomidine

Placebo

Usual standard of care (not including dexmedetomidine) during electrical storm admission

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine infusion during ICU admission for electrical storm

Dexmedetomidine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously admitted at the University of Ottawa Heart Institute's Intensive Cardiac Care Unit with electrical storm and enrolled in the SEDATE trial at that time will be contacted to obtain consent for study participation

You may qualify if:

• 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)

You may not qualify if:

• \- None

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Tachycardia, Ventricular

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

F Daniel Ramirez, MD MSc FRCPC

CONTACT

1+ 613-696-7000; dramirez@ottawaheart.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: January 26, 2026
• Study Start: March 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2025-05

Locations

CA (1)