Mental Health After Dexmedetomidine for Electrical Storm

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Placebo

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: F Daniel Ramirez, MD MSc FRCPC; Phone Number: 1+ 613-696-7000; Email: dramirez@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Francisco D Ramirez, MD MSc FRCPC; Phone Number: 1+ 613 696 7000; Email: dramirez@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dexmedetomidine; Treatment with dexmedetomidine during electrical storm admission	Drug: Dexmedetomidine; Dexmedetomidine infusion during ICU admission for electrical storm
Placebo; Usual standard of care (not including dexmedetomidine) during electrical storm admission	Drug: Placebo; Placebo (standard of care, no dexmedetomidine), for treatment of electrical storm while admitted to ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms	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	Assessed 3-6 months after hospitalization for electrical storm
Depression symptoms	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.	Assessed 3-6 months after hospitalization for electrical storm
Anxiety/fear relating to implantable cardioverter-defibrillator shocks	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	Assessed 3-6 months after hospitalization for electrical storm
Quality of life measure	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	Assessed 3-6 months after hospitalization for electrical storm

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 3, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Mental health; Electrical storm; Ventricular tachycardia
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction; Tachycardia, Ventricular; Psychological Well-Being; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: 20250008-01H

Drug and device information, study documents

• 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