Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial.
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Masse Marie-Hélène, Battista Marie-Claude, Wilcox Mary Elizabeth, Pinto Ruxandra, Marinoff Nicole, D'Aragon Frédérick, St-Arnaud Charles, Mayette Michael, Leclair Marc-André, Quiroz Martinez Hector, Grondin-Beaudoin Brian, Poulin Yannick, Carbonneau Élaine, Seely Andrew J E, Watpool Irene, Porteous Rebecca, Chassé Michaël, Lebrasseur Martine, Lauzier François, Turgeon Alexis F, Bellemare David, Mehta Sangeeta, Charbonney Emmanuel, Belley-Côté Émilie, Botton Édouard, Cohen Dian, Lamontagne François, Adhikari Neill K J, OVATION-65 team members, Canadian Critical Care Trials Group
Аннотация
METHODS AND ANALYSIS: OVATION-65 is an allocation-concealed randomised trial in 7 Canadian hospitals. Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12 hours to maintain MAP ≥65 mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours. Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise. Patients are randomised to permissive hypotension versus usual care for up to 28 days. The primary outcome is high-sensitivity troponin T, a biomarker of cardiac injury, on day 3. Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months). Assessors of biomarkers, mortality and cognitive function are blinded to allocation.
ETHICS AND DISSEMINATION: This protocol has been approved at all sites. Consent is obtained from the eligible patient, the substitute decision-maker if the patient is incapable, or in a deferred fashion where permitted. End-of-grant dissemination plans include presentations, publications and social media platforms and discussion forums.
TRIAL REGISTRATION NUMBER: NCT03431181.