Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.
Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.
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DOI：
10.1136/bmjopen-2019-036671
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发表时间：
2020-09-18
期刊：
影响因子：
2.9
通讯作者：
PREPARE II Investigators
中科院分区：
文献类型：
--
作者：
Russell DW;Casey JD;Gibbs KW;Dargin JM;Vonderhaar DJ;Joffe AM;Ghamande S;Khan A;Dutta S;Landsperger JS;Robison SW;Bentov I;Wozniak JM;Stempek S;White HD;Krol OF;Prekker ME;Driver BE;Brewer JM;Wang L;Lindsell CJ;Self WH;Rice TW;Semler MW;Janz D;PREPARE II Investigators
心血管衰竭是危重成人气管插管时常见的并发症。静脉推注液体是否能防止气管插管期间的心血管衰竭仍不确定。先前的一项随机试验发现，液体团注总体上是无效的，但建议在气管插管期间接受正压通气的患者可能受益。在诱导和插管期间给予液体复苏预防心血管崩溃(PREPARE II)试验是一项在美国13个学术重症监护病房进行的前瞻性、多中心、非盲法随机试验。这项试验将随机选择1065名接受气管插管的危重成人，在诱导和喉镜检查期间有计划地使用正压通气(无创呼吸机或袋罩呼吸机)，接受500毫升静脉注射晶体或不静脉输液。主要结果是心血管衰竭，定义为以下任何一种：收缩压和65毫米汞柱，在诱导到插管后2分钟期间新的或增加的血管加压剂应用，或在诱导到插管后1小时之间心脏骤停或死亡。主要分析将是使用χ2检验对随机接受液体推注的患者和随机未接受液体推注的患者之间的主要结果进行未经调整的意向治疗比较。唯一的次要结果是28天的住院死亡率。报名从2019年2月1日开始，预计2020年6月结束。该试验得到了范德比尔特大学医学中心的中央机构审查委员会或每个试验地点的当地机构审查委员会的批准。研究结果将在同行评议的期刊上发表，并在科学会议上公布。NCT03787732。
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 χ2 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. 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.
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影响因子：
76.2
作者：
Janz, David R.;Casey, Jonathan D.;Rice, Todd W.
通讯作者：
Rice, Todd W.
影响因子：
9.8
作者：
Higgs, A.;McGrath, B. A.;Cook, T. M.
通讯作者：
Cook, T. M.
影响因子：
9.8
作者：
Simpson, G. D.;Ross, M. J.;Ray, D. C.
通讯作者：
Ray, D. C.
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D
影响因子：
8.8
作者：
Martin, Lizabeth D.;Mhyre, Jill M.;Kheterpal, Sachin
通讯作者：
Kheterpal, Sachin