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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Treatment with dexmedetomidine during electrical storm admission |
| |
| Placebo | Usual standard of care (not including dexmedetomidine) during electrical storm admission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine infusion during ICU admission for electrical storm |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- None
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| F Daniel Ramirez, MD MSc FRCPC | Contact | 1+ 613-696-7000 | dramirez@ottawaheart.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo (standard of care, no dexmedetomidine), for treatment of electrical storm while admitted to ICU |
|
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 |
| D006331 |
| Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |