NCT07368062|Recruiting
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)
Loading search results
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm: Outpatient Follow-up of Mental Health INDices (SDATE OF MIND)
Sponsor study identifier
observational
70
1 country
1
Study Start
March 15, 2025
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2025
Actual (reported)June 3, 2025
Actual (reported)January 26, 2026
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Treatment with dexmedetomidine during electrical storm admission
Usual standard of care (not including dexmedetomidine) during electrical storm admission
Dexmedetomidine infusion during ICU admission for electrical storm
Placebo (standard of care, no dexmedetomidine), for treatment of electrical storm while admitted to ICU
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
First Submitted
June 3, 2025
First Posted
January 26, 2026
Study Start
March 15, 2025
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mindfulness-Assisted Psychedelic Therapy
Contact the study team to confirm eligibility.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 1, 2026
Record last verified: 2026-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: