Sedation Clinical Trial
— DEXSEDATIONOfficial title:
Risk Prediction and Consequences of Dexmedetomidine-associated Hemodynamic Instability in Intubated Mechanically Ventilated Intensive Care Unit Patients
Verified date | January 2021 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hypotension and bradycardia have been commonly associated with dexmedetomidine therapy, occurring in 13% to 68% and 1% to 42% of patients, respectively. The variability in reported incidence may be partially attributed to inconsistent definitions and study populations. The significance of this hemodynamic instability is not only highlighted by its high incidence but also the need for corrective interventions. In one study, hemodynamic instability requiring clinical intervention occurred in nearly one third of ICU patients receiving dexmedetomidine. Moreover, patients who experienced dexmedetomidine-associated hypotension had a higher mortality rate than those who did not.
Status | Suspended |
Enrollment | 250 |
Est. completion date | August 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Adult patients (18-65 years old) - admitted to Intensive care units in Assiut university Hospital - requiring endotracheal intubation, mechanical ventilation and light to moderate sedation - of an estimated duration not less than 24h. Exclusion Criteria: - History of coronary care unit admission. - Severe traumatic brain injury. - Low baseline arterial blood pressure defined as SBP <100 mm Hg or mean arterial blood pressure (MAP) <70 mm Hg in the 60 minutes preceding dexmedetomidine initiation. - Slow baseline heart rate was <70 bpm in the 60 minutes preceding dexmedetomidine initiation. - Spinal cord injury. - Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator. - Patients who are admitted with a primary diagnosis of substance withdrawal. - Pregnant females. - Patients who are incarcerated. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut university main hospital, Trauma ICU | Assiut | Assiut Governorate |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of hemodynamic instability events during dexmedetomidine | The primary end point will be the occurrence of at least 1 episode of clinically significant hemodynamic instability during dexmedetomidine therapy defined as systolic blood pressure (SBP) < 80 mm Hg, diastolic blood pressure (DBP) <50 mm Hg, or heart rate <50 beats per minute (bpm) To qualify as an event, the hemodynamic variable had to remain below the specified threshold for at least 2 consecutive readings (=30 minutes of recorded hemodynamic instability). The cumulative incidence of hemodynamic instability events during dexmedetomidine sedation will be plotted and Cox proportional hazards models will be constructed to determine hazard ratios (HRs) and 95% confidence intervals (CIs) for the risk factors of hemodynamic instability during dexmedetomidine therapy. | 24 hours |
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