Recruiting

ES & Quality Of Life

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT07368062

Conditions

Mental Health

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

Placebo

Study Details

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

Study ID

NCT07368062

Start date

Mar 15, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Dexmedetomidine

Treatment with dexmedetomidine during electrical storm admission

Placebo

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

Interventions

Dexmedetomidine

Dexmedetomidine infusion during ICU admission for electrical storm

Placebo

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

Primary outcome measure

  • Post-traumatic stress disorder symptoms [ Time Frame: Assessed 3-6 months after hospitalization for electrical storm ]

Central Contacts and Locations

Central contacts

F Daniel Ramirez, MD MSc FRCPC

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

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Francisco D Ramirez, MD MSc FRCPC

1+ 613 696 7000dramirez@ottawaheart.ca

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Electrical storm
  • Ventricular tachycardia
  • Dexmedetomidine
  • Mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-07-01.