Mental Health After Dexmedetomidine for Electrical Storm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Placebo.
- Who it may be relevant to
- Registry conditions: Mental Health. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm: Outpatient Follow-up of Mental Health INDices (SDATE OF MIND)
Overview
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.
Interventions
- Drug Dexmedetomidine
Dexmedetomidine infusion during ICU admission for electrical storm - Drug Placebo
Placebo (standard of care, no dexmedetomidine), for treatment of electrical storm while admitted to ICU
Primary outcome measures
- Post-traumatic stress disorder symptoms [Time frame: Assessed 3-6 months after hospitalization for electrical storm]
Secondary outcome measures (4)
- Anxiety symptoms [Time frame: Assessed 3-6 months after hospitalization for electrical storm]
- Depression symptoms [Time frame: Assessed 3-6 months after hospitalization for electrical storm]
- Anxiety/fear relating to implantable cardioverter-defibrillator shocks [Time frame: Assessed 3-6 months after hospitalization for electrical storm]
- Quality of life measure [Time frame: Assessed 3-6 months after hospitalization for electrical storm]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- University of Ottawa Heart Institute — Ottawa
Identifiers
NCT: NCT07368062 · 20250008-01H