Status:
ACTIVE_NOT_RECRUITING
Optimal VAsopressor TitraTION in Patients 65 Years and Older
Lead Sponsor:
Université de Sherbrooke
Conditions:
Vasopressors
Hypotension
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
We have designed OVATION-65 to evaluate the effects of permissive low blood pressure compared to usual care on markers of organ injury and survival in older patients.
Detailed Description
Background: When it is severe, hypotension compromises tissue perfusion and organ function, leading to multiple organ failure and death. Commonly in intensive care units (ICUs), excessive vasodilatio...
Eligibility Criteria
Inclusion
- Age 65 years or older
- Working diagnosis of vasodilatory hypotension as assessed by treating team
- Vasopressors started for 12 hours or less (window from ICU admission after/during adequate fluid resuscitation as assessed by treating physician)
- Vasopressors expected for 6 additional hours as assessed by the treating team
Exclusion
- Actively treated for spinal cord injury or acute brain injury
- Vasopressors being given solely for bleeding, acute ventricular failure or post-cardiopulmonary bypass vasoplegia
- Lacking commitment to life-sustaining therapies (expected withdrawal of life-sustaining treatments within the next 48 hours
- Death perceived as imminent
- Previously enrolled in OVATION-65
- Organ transplant within the last year
- Extra corporeal life support at baseline
- The treating physician(s) lacks equipoise regarding the overall effects of permissive hypotension versus usual care on patient important outcomes.
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT03431181
Start Date
February 16 2018
End Date
December 31 2024
Last Update
May 16 2024
Active Locations (1)
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1
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada, J1H5N4