Mental Health After Dexmedetomidine for Electrical Storm
ConditionMental Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOttawa Heart Institute Research Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial population
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
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Dexmedetomidine
DrugDexmedetomidine infusion during ICU admission for electrical storm
Placebo
DrugPlacebo (standard of care, no dexmedetomidine), for treatment of electrical storm while admitted to ICU
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine1 intervention
Group B: Placebo1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Assessed 3-6 months after hospitalization for electrical stormSecondary outcomes
1
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
Time frame
Assessed 3-6 months after hospitalization for electrical storm2
Depression symptoms
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.
Time frame
Assessed 3-6 months after hospitalization for electrical storm3
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
Time frame
Assessed 3-6 months after hospitalization for electrical storm4
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
Time frame
Assessed 3-6 months after hospitalization for electrical stormSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov