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Not Applicable
Vasopressor Titration for Low Blood Pressure (OVATION-65 Trial)
N/A
Waitlist Available
Led By Neill Adhikari, MDCM MSc
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Vasopressors expected for 6 additional hours as assessed by the treating team
Age 65 years or older
Must not have
Organ transplant within the last year
Vasopressors being given solely for bleeding, acute ventricular failure or post-cardiopulmonary bypass vasoplegia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of permissive low blood pressure to usual care on organ injury and survival in older patients.
Who is the study for?
This trial is for people aged 65 or older who have low blood pressure due to vasodilation. They must have started on vasopressors within the last 12 hours and are expected to need them for at least another 6 hours, as determined by their medical team.
What is being tested?
OVATION-65 aims to compare two blood pressure management strategies in older patients: a lower target mean arterial pressure (MAP) of 60-65 mmHg versus usual care practices. The study will assess organ injury markers and survival rates.
What are the potential side effects?
Potential side effects may include changes in heart rate, irregular heartbeat, headaches, dizziness, or skin reactions at the infusion site due to vasopressor use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctors plan to continue my blood pressure medication for at least 6 more hours.
Select...
I am 65 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had an organ transplant in the past year.
Select...
I am on medication to raise my blood pressure due to bleeding, heart failure, or after heart surgery.
Select...
I am currently receiving treatment for a spinal cord or acute brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma high-sensitivity cardiac troponin T at day 3 (primary mechanistic outcome)
Secondary study objectives
6-month cognitive impairment
Biomarkers of ascorbic acid deficiency-related organ injury (outcome for ancillary study)
Concentration of biomarker associated with cardiac wall stress
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MAP target 60-65 mmHgExperimental Treatment1 Intervention
Treating teams will adjust vasopressors to a target MAP range of 60 to 65 mmHg, avoiding vasopressor-induced MAP above this range.
Group II: Usual CareActive Control1 Intervention
Patients in the control arm will receive usual care (as per local practices).
Find a Location
Who is running the clinical trial?
Université de SherbrookeLead Sponsor
307 Previous Clinical Trials
77,465 Total Patients Enrolled
Neill Adhikari, MDCM MScPrincipal InvestigatorSunnybrook Health Sciences Centre, University of Toronto
François Lamontagne, MD FRCPC MScPrincipal InvestigatorUniversity of Sherbrooke and CIUSSS de l'Estrie-CHUS
1 Previous Clinical Trials
872 Total Patients Enrolled