Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.
adult intensive & critical care
clinical trials
thoracic medicine
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
18 09 2020
18 09 2020
Historique:
entrez:
19
9
2020
pubmed:
20
9
2020
medline:
15
5
2021
Statut:
epublish
Résumé
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. 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 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. NCT03787732.
Identifiants
pubmed: 32948554
pii: bmjopen-2019-036671
doi: 10.1136/bmjopen-2019-036671
pmc: PMC7511643
doi:
Banques de données
ClinicalTrials.gov
['NCT03787732']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
e036671Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL143053
Pays : United States
Organisme : NHLBI NIH HHS
ID : K08 HL148514
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL087738
Pays : United States
Organisme : NHLBI NIH HHS
ID : K12 HL133117
Pays : United States
Organisme : NHLBI NIH HHS
ID : K23 HL153584
Pays : United States
Investigateurs
Kevin W Gibbs
(KW)
Simanta Dutta
(S)
Stephen P Peters
(SP)
Muhammad Ali
(M)
Rita N Bakhru
(RN)
Scott Bauer
(S)
Christina R Bellinger
(CR)
Amanda M Brown
(AM)
Blair Brown
(B)
Jerri Brown
(J)
Caitlin Bumgarner
(C)
Wendy Butcher
(W)
Megan Caudle
(M)
Arjun B Chatterjee
(AB)
David J Chodos
(DJ)
Gerardo Corcino
(G)
Nathan S Cutler
(NS)
Travis L Dotson
(TL)
Daniel C Files
(DC)
Jonathan L Forbes
(JL)
John P Gaillard
(JP)
Katherine A Gershner
(KA)
Shannon Ginty
(S)
Kiadrick R Hood
(KR)
April Hazelwood
(A)
Katherine Hendricks
(K)
Kelly Jacobus
(K)
Jonathan T Jaffe
(JT)
Stacy Kay
(S)
Chad A Kloefkorn
(CA)
Jennifer Krall
(J)
Margo T Lannan
(MT)
Cornelia Lane
(C)
Cynthia Lanning
(C)
Jessica Lyons
(J)
William I Mariencheck
(WI)
Chad R Marion
(CR)
Matthew A Maslonka
(MA)
Sara McClintock
(S)
Nathaniel M Meier
(NM)
Matthew C Miles
(MC)
Peter J Miller
(PJ)
Sophia Mitchell
(S)
Wendy C Moore
(WC)
Katherine Moss
(K)
Andrew M Namen
(AM)
Dustin L Norton
(DL)
Stella B Ogake
(SB)
Jill A Ohar
(JA)
Victor E Ortega
(VE)
Jessica A Palakshappa
(JA)
Rodolfo M Pascual
(RM)
Sandi Pascual
(S)
Aaron Pickens
(A)
Adam R Schertz
(AR)
Matt Strong
(M)
Alexander O Sy
(AO)
Braghadheeswar Thyagarajan
(B)
Amy Townsend
(A)
Russell Worthen
(R)
Michael Wlodarski
(M)
Charles Yarbrough
(C)
Caroline York
(C)
Jonathan D Casey
(JD)
Janna S Landsperger
(JS)
Li Wang
(L)
Todd W Rice
(TW)
Matthew W Semler
(MW)
Wesley H Self
(WH)
Bradley Lloyd
(B)
James Dargin
(J)
Joanne Wozniak
(J)
Susan Stempek
(S)
Christopher Adler
(C)
Ahmed Agameya
(A)
Michael Colancecco
(M)
Daniel Fitelson
(D)
Joshua Giaccotto
(J)
Gena Han
(G)
Louise Kane
(L)
Ezra Miller
(E)
Timothy Noland
(T)
Jaqueline Price
(J)
Joseph Plourde
(J)
Emily Adams
(E)
Fraser Mackay
(F)
Laura Mahoney
(L)
Avignat Patel
(A)
Michael Plourde
(M)
Zena Saadeh
(Z)
Sara Shadchehr
(S)
Sandeep Somalaraju
(S)
Eleanor Summerhill
(E)
Ryan Webster
(R)
Jordan Winnicki
(J)
Ekaterina Yavarovich
(E)
Derek W Russell
(DW)
Sarah W Robison
(SW)
Sheetal Gandotra
(S)
Swati Gulati
(S)
Anna Altz-Stamm
(A)
Cristina Bardita
(C)
Mary Clay Boone
(MC)
Joe W Chiles
(JW)
Kristina Collins
(K)
Abby Drescher
(A)
Kevin G Dsouza
(KG)
Janna Dunn
(J)
Stacy Ejem
(S)
Josh Gautney
(J)
Nicole Harris
(N)
Savannah Herder
(S)
Tamer Hudali
(T)
R Chad Wade
(R)
Rutwij Joshi
(R)
Daniel Kelmenson
(D)
Anne Merrill Mason
(AM)
Scott R Merriman
(SR)
Takudzwa Mkorombindo
(T)
Megan Moore
(M)
Jada Nowak
(J)
Kate O'Connor
(K)
David B Page
(DB)
D Sheylan
(D)
G Patel
(G)
Bruno Pereira
(B)
Lisa Sarratt
(L)
Tabitha Stewart
(T)
William S Stigler
(WS)
Kadambari Vijaykumar
(K)
Gina White
(G)
Micah R Whitson
(MR)
Derek J Vonderhaar
(DJ)
Kevin M Dischert
(KM)
Aaron M Joffe
(AM)
Itay Bentov
(I)
Christopher Barnes
(C)
Andrew M Walters
(AM)
Shekhar Ghamande
(S)
Heath D White
(HD)
Alejandro C Arroliga
(AC)
Tasnim Lat
(T)
Akram Khan
(A)
Olivia F Krol
(OF)
Stephanie Nonas
(S)
Milad K Jouzestani
(MK)
Raya Adi
(R)
Chandani Anandkat
(C)
Hanae Benchbani
(H)
Matthew G Drake
(MG)
Makrina N Kamel
(MN)
Ramanpreet Randhawa
(R)
Jessica L Tsui
(JL)
Matthew E Prekker
(ME)
Brian E Driver
(BE)
Joseph M Brewer
(JM)
David R Janz
(DR)
Christopher J Lindsell
(CJ)
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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