Vasopressor Titration for Low Blood Pressure

(OVATION-65 Trial)

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Spinal cord injury, Brain injury, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 28 days

159 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

François Lamontagne, MD FRCPC MSc

Principal Investigator

University of Sherbrooke and CIUSSS de l'Estrie-CHUS

Neill Adhikari, MDCM MSc

Principal Investigator

Sunnybrook Health Sciences Centre, University of Toronto

Eligibility Criteria

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.

Inclusion Criteria

I started vasopressors within 12 hours of ICU admission after getting enough fluids.

My doctors plan to continue my blood pressure medication for at least 6 more hours.

I am 65 years old or older.

Exclusion Criteria

The treating physician(s) lacks equipoise regarding the overall effects of permissive hypotension versus usual care on patient important outcomes.

I have had an organ transplant in the past year.

Extra corporeal life support at baseline

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to target MAP 60-65 mmHg vs. usual care and receive vasopressor therapy accordingly

28 days

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including organ function and cognitive assessments

6 months

Regular follow-up assessments, including phone call at 6 months

Long-term follow-up

Assessment of mortality and cognitive impairment at 6 months

6 months

Treatment Details

Interventions

• Permissive Low Blood Pressure
• Usual care

Trial Overview 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.

Participant Groups

Group I: MAP target 60-65 mmHg Experimental Treatment 1 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 Care Active Control 1 Intervention

Patients in the control arm will receive usual care (as per local practices).

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+