Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial. Issue 9 (18th September 2020)

• Record Type: Journal Article
• Authors: Russell, Derek W; Casey, Jonathan D; Gibbs, Kevin W; Dargin, James M; Vonderhaar, Derek J; Joffe, A M; Ghamande, Shekhar; Khan, Akram; Dutta, Simanta; Landsperger, Janna S; Robison, Sarah W; Bentov, Itay; Wozniak, Joanne M; Stempek, Susan; White, Heath D; Krol, Olivia F; Prekker, Matthew E; Driver, Brian E; Brewer, Joseph M; Wang, Li; Lindsell, Christopher John; Self, Wesley H; Rice, Todd W; Semler, Matthew W; Janz, David
• Other Names: author non-byline.; Gibbs Kevin W author non-byline.; Dutta Simanta author non-byline.; Peters Stephen P author non-byline.; Ali Muhammad author non-byline.; Bakhru Rita N author non-byline.; Bauer Scott author non-byline.; Bellinger Christina R author non-byline.; Brown Amanda M author non-byline.; Brown Blair author non-byline.; Brown Jerri author non-byline.; Bumgarner Caitlin author non-byline.; Butcher Wendy author non-byline.; Caudle Megan author non-byline.; Chatterjee Arjun B author non-byline.; Chodos David J author non-byline.; Corcino Gerardo author non-byline.; Cutler Nathan S author non-byline.; Dotson Travis L author non-byline.; Files Daniel C author non-byline.; Forbes Jonathan L author non-byline.; Gaillard John P author non-byline.; Gershner Katherine A author non-byline.; Ginty Shannon author non-byline.; Hood Kiadrick R author non-byline.; Hazelwood April author non-byline.; Hendricks Katherine author non-byline.; Jacobus Kelly author non-byline.; Jaffe Jonathan T author non-byline.; Kay Stacy author non-byline.; Kloefkorn Chad A author non-byline.; Krall Jennifer author non-byline.; Lannan Margo T author non-byline.; Lane Cornelia author non-byline.; Lanning Cynthia author non-byline.; Lyons Jessica author non-byline.; Mariencheck William I author non-byline.; Marion Chad R author non-byline.; Maslonka Matthew A author non-byline.; McClintock Sara author non-byline.; Meier Nathaniel M author non-byline.; Miles Matthew C author non-byline.; Miller Peter J author non-byline.; Mitchell Sophia author non-byline.; Moore Wendy C author non-byline.; Moss Katherine author non-byline.; Namen Andrew M author non-byline.; Norton Dustin L author non-byline.; Ogake Stella B author non-byline.; Ohar Jill A author non-byline.; Ortega Victor E author non-byline.; Palakshappa Jessica A author non-byline.; Pascual Rodolfo M author non-byline.; Pascual Sandi author non-byline.; Pickens Aaron author non-byline.; Schertz Adam R author non-byline.; Strong Matt author non-byline.; Sy Alexander O author non-byline.; Thyagarajan Braghadheeswar author non-byline.; Townsend Amy author non-byline.; Worthen Russell author non-byline.; Wlodarski Michael author non-byline.; Yarbrough Charles author non-byline.; York Caroline author non-byline.; Casey Jonathan D author non-byline.; Landsperger Janna S author non-byline.; Wang Li author non-byline.; Rice Todd W author non-byline.; Semler Matthew W author non-byline.; Self Wesley H author non-byline.; Lloyd Bradley author non-byline.; Dargin James author non-byline.; Wozniak Joanne author non-byline.; Stempek Susan author non-byline.; Adler Christopher author non-byline.; Agameya Ahmed author non-byline.; Colancecco Michael author non-byline.; Fitelson Daniel author non-byline.; Giaccotto Joshua author non-byline.; Han Gena author non-byline.; Kane Louise author non-byline.; Miller Ezra author non-byline.; Noland Timothy author non-byline.; Price Jaqueline author non-byline.; Plourde Joseph author non-byline.; Adams Emily author non-byline.; Mackay Fraser author non-byline.; Mahoney Laura author non-byline.; Patel Avignat author non-byline.; Plourde Michael author non-byline.; Saadeh Zena author non-byline.; Shadchehr Sara author non-byline.; Somalaraju Sandeep author non-byline.; Summerhill Eleanor author non-byline.; Webster Ryan author non-byline.; Winnicki Jordan author non-byline.; Yavarovich Ekaterina author non-byline.; Russell Derek W author non-byline.; Robison Sarah W author non-byline.; Gandotra Sheetal author non-byline.; Gulati Swati author non-byline.; Altz-Stamm Anna author non-byline.; Bardita Cristina author non-byline.; Boone Mary Clay author non-byline.; Chiles Joe W author non-byline.; Collins Kristina author non-byline.; Drescher Abby author non-byline.; Dsouza Kevin G author non-byline.; Dunn Janna author non-byline.; Ejem Stacy author non-byline.; Gautney Josh author non-byline.; Harris Nicole author non-byline.; Herder Savannah author non-byline.; Hudali Tamer author non-byline.; Chad Wade R author non-byline.; Joshi Rutwij author non-byline.; Kelmenson Daniel author non-byline.; Mason Anne Merrill author non-byline.; Merriman Scott R author non-byline.; Mkorombindo Takudzwa author non-byline.; Moore Megan author non-byline.; Nowak Jada author non-byline.; O'Connor Kate author non-byline.; Page David B author non-byline.; Sheylan D author non-byline.; Patel G author non-byline.; Pereira Bruno author non-byline.; Sarratt Lisa author non-byline.; Stewart Tabitha author non-byline.; Stigler William S author non-byline.; Vijaykumar Kadambari author non-byline.; White Gina author non-byline.; Whitson Micah R author non-byline.; Vonderhaar Derek J author non-byline.; Dischert Kevin M author non-byline.; Joffe Aaron M author non-byline.; Bentov Itay author non-byline.; Barnes Christopher author non-byline.; Walters Andrew M author non-byline.; Ghamande Shekhar author non-byline.; White Heath D author non-byline.; Arroliga Alejandro C author non-byline.; Lat Tasnim author non-byline.; Khan Akram author non-byline.; Krol Olivia F author non-byline.; Nonas Stephanie author non-byline.; Jouzestani Milad K author non-byline.; Adi Raya author non-byline.; Anandkat Chandani author non-byline.; Benchbani Hanae author non-byline.; Drake Matthew G author non-byline.; Kamel Makrina N author non-byline.; Randhawa Ramanpreet author non-byline.; Tsui Jessica L author non-byline.; Prekker Matthew E author non-byline.; Driver Brian E author non-byline.; Brewer Joseph M author non-byline.; Janz David R author non-byline.; Lindsell Christopher J author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 9(2020)
• Publication Date: 2020-09-18
• Subjects: adult intensive & critical care -- thoracic medicine -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-036671
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation. Methods and analysis: The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ 2 test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020. Ethics and dissemination: The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences. Trial registration number: NCT03787732 .