Mental health and quality of life after ICU treatment with dexmedetomidine for electrical storm
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm: Outpatient Follow-up of Mental Health INDices (SDATE OF MIND)
This follows people treated for electrical storm in the ICU to see if receiving dexmedetomidine is linked to their mental health and quality of life 3–6 months later.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT07368062 on ClinicalTrials.gov |
What this trial studies
This is an observational follow-up of participants from the SEDATE trial who were admitted to an ICU with electrical storm. Consenting participants will complete standardized questionnaires measuring mental health and health-related quality of life between 3 and 6 months after their ICU admission. Each questionnaire takes about 5–15 minutes to complete, and questionnaires may be completed at a scheduled follow-up visit to the University of Ottawa Heart Institute or by other arranged means. The goal is to describe the mental health burden after ICU care and treatments received during electrical storm to inform improvements in post-ICU care.
Who should consider this trial
Good fit: People who were admitted to an ICU with electrical storm within the past 6 months and who previously participated in the SEDATE trial are eligible.
Not a fit: Patients who did not take part in the SEDATE trial, were not admitted to an ICU for electrical storm, or cannot complete follow-up questionnaires are unlikely to benefit directly from this follow-up.
Why it matters
Potential benefit: If successful, the findings could lead to better post-ICU mental health screening and support for survivors of electrical storm.
How similar studies have performed: Post-ICU mental health problems are well documented in other critical-care populations, but using SEDATE participants to examine links with dexmedetomidine exposure is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: F Daniel Ramirez, MD MSc FRCPC
- Email: dramirez@ottawaheart.ca
- Phone: 1+ 613-696-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.