Table 1 Eligibility Criteria
PRE-TRIAL PERIOD | DURING-TRIAL PERIOD | |
|---|---|---|
Pre-trial group | Non-enrolled group | Usual care control group |
Inclusion criteria | Inclusion criteria | Inclusion criteria |
•-At least 65 years of age •-Admitted to ICU with hypotension as a diagnosis •-Receiving vasopressor therapy for at least 6 consecutive hours in the ICU during index hospitalization | •-At least 65 years of age •-Admitted to ICU with hypotension as a diagnosis •-Receiving vasopressor therapy for at least 6 consecutive hours in the ICU during index hospitalization | •-At least 65 years of age •-Working diagnosis of vasodilatory hypotension as assessed by treating team •-Vasopressors started < 12 h before randomization •-Vasopressors expected for 6 additional hours as assessed by the treating team |
Exclusion criteria | Exclusion criteria | Exclusion criteria |
•-Treated for brain or spinal injury or acute brain injury during index hospitalization •-Vasopressors administered solely for: bleeding, acute ventricular failure or post-cardiopulmonary bypass vasoplegia •-Organ transplant within the past year •-Received ECMO during index hospitalization | •-Treated for brain or spinal injury or acute brain injury during index hospitalization •-Vasopressors administered solely for: bleeding, acute ventricular failure or post-cardiopulmonary bypass vasoplegia •-Organ transplant within the past year •-Received ECMO during index hospitalization | •-Actively treated for brain injury or spinal cord injury •-Vasopressors being given solely for bleeding, acute ventricular failure or post-cardiopulmonary bypass vasoplegia •-Lacking commitment to life-sustaining therapies •-Death perceived as imminent •-Previously enrolled in OVATION-65 •-Organ transplant within the last year •-ECMO at baseline •-The treating physician(s) lacks equipoise regarding the overall effects of permissive hypotension versus usual care on patient important outcomes |