Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial. Issue 11 (14th November 2020)

• Record Type: Journal Article
• Authors: 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
• Other Names: author non-byline.; Adhikari Neill KJ author non-byline.; Lamontagne François author non-byline.; Wilcox Mary Elizabeth author non-byline.; Battista Marie-Claude author non-byline.; Masse Marie-Hélène author non-byline.; Laupacis Andreas author non-byline.; Griffith Lauren author non-byline.; Halpern Scott author non-byline.; Robert-Petit Louise author non-byline.; Thibault Marie-Ève author non-byline.; Boisvert François-Michel author non-byline.; Tai Lee Hwa author non-byline.; Parent Jean-Luc author non-byline.; Roucou Xavier author non-byline.; D'Aragon Frédérick author non-byline.; Leclair Marc-André author non-byline.; Mayette Michaël author non-byline.; Poulin Yannick author non-byline.; Quiroz-Martinez Hector author non-byline.; St-Arnaud Charles author non-byline.; Carbonneau Élaine author non-byline.; Côté Line author non-byline.; Ladouceur Marilène author non-byline.; Marchand Joannie author non-byline.; Turcotte Noémie author non-byline.; Chassé Michaël author non-byline.; Lebrasseur Martine author non-byline.; Benettaib Fatna author non-byline.; Boumahni Dounia author non-byline.; Cantin Marie-Ève author non-byline.; Ghamraoui Ali author non-byline.; Salame Maya author non-byline.; Seely Andrew author non-byline.; Watpool Irene author non-byline.; Porteous Rebecca author non-byline.; Miezitis Sydney author non-byline.; Amaral Andre Carlos author non-byline.; Cuthbertson Brian H author non-byline.; Fowler Robert A author non-byline.; Scales Damon C author non-byline.; Marinoff Nicole author non-byline.; Kaur Navjot author non-byline.; Mohammed Wael author non-byline.; Lauzier François author non-byline.; Turgeon Alexis author non-byline.; Francoeur Charles author non-byline.; Leblanc Guillaume author non-byline.; Bellemare David author non-byline.; Costerousse Olivier author non-byline.; Grenier Stéphanie author non-byline.; Guilbault Gabrielle author non-byline.; Daigle Marjorie author non-byline.; Cloutier Ève author non-byline.; St-Hilaire Isabelle author non-byline.; Mehta Sangeeta author non-byline.; Munshi Laveena author non-byline.; Shah Sumesh author non-byline.; Singh Jeffrey author non-byline.; Walczak Karolina author non-byline.; Rochwerg Bram author non-byline.; Millen Tina author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 11(2020)
• Publication Date: 2020-11-14
• Subjects: adult intensive & critical care -- clinical trials -- clinical chemistry; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-037947
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Vasodilatory hypotension is common among intensive care unit (ICU) patients; vasopressors are considered standard of care. However, optimal mean arterial pressure (MAP) targets for vasopressor titration are unknown. The objective of the Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65) trial is to ascertain the effect of permissive hypotension (vasopressor titration to achieve MAP 60–65 mm Hg) versus usual care on biomarkers of organ injury in hypotensive patients aged ≥65 years. 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 .