TABLE 1.
Characteristic | Asfar et al (27) | Lamontagne et al (28) | Lamontagne et al (4) |
---|---|---|---|
Trial registration | NCT01149278 | NCT01800877 | ISRCTN10580502 |
Design | Parallel group RCT | Parallel group RCT | Parallel group RCT |
Location | France | Canada and United States | United Kingdom |
Funding source | Government | Government | Government |
Setting | ICU | ICU | ICU |
Sample size | 776 (97% of anticipated 800) | 120 | 2,600 |
Recruitment years | 2010–2011 | 2013–2014 | 2017–2019 |
Inclusion criteria | > 18 yr | > 16 yr | ≥65 yr |
Septic shocka refractory to fluid resuscitation (requiring ≥0.1 μg/kg/min norepinephrine or epinephrine) | Receiving vasopressors for vasodilatory shock | Vasodilatory hypotension | |
Evaluated within 6 hr of vasopressor initiation | Adequately fluid resuscitated as per treating physician | ≥1 hr of vasopressor, started within prior 6 hr (if norepinephrine, then ≥0.1 µg/kg/min) | |
Vasopressor expected for ≥6 more hr | Adequate fluid resuscitation completed or ongoing | ||
Vasopressor expected for ≥6 more hr | |||
Exclusion criteria | Pregnancy | Received vasopressors for > 24 hr | Vasopressors used solely for bleeding, acute ventricular failure, or after cardiopulmonary bypass |
Recent participation in another study with mortality as primary endpoint | Expected to die within 48 hr | Ongoing treatment for brain or spinal cord injury | |
Decision not to resuscitate | Required vasopressor for reasons unrelated to hypotension | Death perceived as imminent | |
Main cause of hypotension cardiogenic, hemorrhagic or neurogenic shock, or immediately after surgery | |||
Intervention | Target MAP 65–70 mm Hg | Target MAP 60–65 mm Hg | Target MAP 60–65 mm Hg |
Control | Target MAP 80–85 mm Hg | Target MAP 75–80 mm Hg | Usual care as per treating clinician |
Duration of intervention period | 5 d or until weaned from vasopressor support | Entire period of vasopressor infusion, ending when MAP maintained within or above prescribed range without vasopressors, capped at 28 d | At any time vasopressors required from randomization until ICU discharge |
Length of follow-up | 90 d | 180 d | 1 yr |
RCT = randomized clinical trial, MAP = mean arterial pressure.
The criteria for septic shock were the official criteria of the American College of Chest Physicians/Society of Critical Care Medicine, that is, sepsis plus arterial hypotension (systolic blood pressure < 90 mm Hg) refractory to fluid resuscitation (minimum 30 mL/kg within 6 hr prior to the start of catecholamines) and requiring vasopressor support.