The SPICE III study protocol and analysis plan

a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients (Protocol)

Yahya Shehabi, Andrew B. Forbes, Yaseen Arabi, Frances Bass, Rinaldo Bellomo, Suhaini Kadiman, Belinda D. Howe, Colin McArthur, Michael C. Reade, Ian Seppelt, Jukka Takala, Steve Webb, Matthew P. Wise, for the SPICE III study investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre

Research output: Contribution to journalArticleOtherpeer-review

4 Citations (Scopus)

Abstract

BACKGROUND: Sedation strategy in critically ill patients who are mechanically ventilated is influenced by patient-related factors, choice of sedative agent and the intensity or depth of sedation prescribed. The impact of sedation strategy on outcome, in particular when delivered early after initiation of mechanical ventilation, is uncertain. OBJECTIVES: To present the protocol and analysis plan of a large randomised clinical trial investigating the effect of a sedation strategy, in critically ill patients who are mechanically ventilated, based on a protocol targeting light sedation using dexmedetomidine as the primary sedative, termed "early goal-directed sedation", compared with usual practice. METHODS: This is a multinational randomised clinical trial in adult intensive care patients expected to require mechanical ventilation for longer than 24 hours. The main exclusion criteria include suspected or proven primary brain pathology or having already been intubated or sedated in an intensive care unit for longer than 12 hours. Randomisation occurs via a secured website with baseline stratification by site and suspected or proven sepsis. The primary outcome is 90-day all-cause mortality. Secondary outcomes include death, institutional dependency, cognitive function and health-related quality of life 180 days after randomisation, as well as delirium free, coma-free and ventilation-free days at 28 days after randomisation. A predefined subgroup analysis will also be conducted. Analyses will be on an intention-to-treat basis and in accordance with this pre-specified analysis plan. CONCLUSION: SPICE III is an ongoing large scale clinical trial. Once completed, it will inform sedation practice in critically ill patients who are ventilated.
Original languageEnglish
Pages (from-to)318-326
Number of pages9
JournalCritical Care and Resuscitation
Volume19
Issue number4
Publication statusPublished - 1 Dec 2017

Cite this

Shehabi, Y., Forbes, A. B., Arabi, Y., Bass, F., Bellomo, R., Kadiman, S., ... for the SPICE III study investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre (2017). The SPICE III study protocol and analysis plan: a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients (Protocol). Critical Care and Resuscitation, 19(4), 318-326.
Shehabi, Yahya ; Forbes, Andrew B. ; Arabi, Yaseen ; Bass, Frances ; Bellomo, Rinaldo ; Kadiman, Suhaini ; Howe, Belinda D. ; McArthur, Colin ; Reade, Michael C. ; Seppelt, Ian ; Takala, Jukka ; Webb, Steve ; Wise, Matthew P. ; for the SPICE III study investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre. / The SPICE III study protocol and analysis plan : a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients (Protocol). In: Critical Care and Resuscitation. 2017 ; Vol. 19, No. 4. pp. 318-326.
@article{58905aab757f451c885a0da8bd8fc729,
title = "The SPICE III study protocol and analysis plan: a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients (Protocol)",
abstract = "BACKGROUND: Sedation strategy in critically ill patients who are mechanically ventilated is influenced by patient-related factors, choice of sedative agent and the intensity or depth of sedation prescribed. The impact of sedation strategy on outcome, in particular when delivered early after initiation of mechanical ventilation, is uncertain. OBJECTIVES: To present the protocol and analysis plan of a large randomised clinical trial investigating the effect of a sedation strategy, in critically ill patients who are mechanically ventilated, based on a protocol targeting light sedation using dexmedetomidine as the primary sedative, termed {"}early goal-directed sedation{"}, compared with usual practice. METHODS: This is a multinational randomised clinical trial in adult intensive care patients expected to require mechanical ventilation for longer than 24 hours. The main exclusion criteria include suspected or proven primary brain pathology or having already been intubated or sedated in an intensive care unit for longer than 12 hours. Randomisation occurs via a secured website with baseline stratification by site and suspected or proven sepsis. The primary outcome is 90-day all-cause mortality. Secondary outcomes include death, institutional dependency, cognitive function and health-related quality of life 180 days after randomisation, as well as delirium free, coma-free and ventilation-free days at 28 days after randomisation. A predefined subgroup analysis will also be conducted. Analyses will be on an intention-to-treat basis and in accordance with this pre-specified analysis plan. CONCLUSION: SPICE III is an ongoing large scale clinical trial. Once completed, it will inform sedation practice in critically ill patients who are ventilated.",
author = "Yahya Shehabi and Forbes, {Andrew B.} and Yaseen Arabi and Frances Bass and Rinaldo Bellomo and Suhaini Kadiman and Howe, {Belinda D.} and Colin McArthur and Reade, {Michael C.} and Ian Seppelt and Jukka Takala and Steve Webb and Wise, {Matthew P.} and {for the SPICE III study investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre}",
year = "2017",
month = "12",
day = "1",
language = "English",
volume = "19",
pages = "318--326",
journal = "Critical Care and Resuscitation",
issn = "1441-2772",
publisher = "Australasian Medical Publishing Co. Pty Ltd. (AMPCo)",
number = "4",

}

Shehabi, Y, Forbes, AB, Arabi, Y, Bass, F, Bellomo, R, Kadiman, S, Howe, BD, McArthur, C, Reade, MC, Seppelt, I, Takala, J, Webb, S, Wise, MP & for the SPICE III study investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre 2017, 'The SPICE III study protocol and analysis plan: a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients (Protocol)', Critical Care and Resuscitation, vol. 19, no. 4, pp. 318-326.

The SPICE III study protocol and analysis plan : a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients (Protocol). / Shehabi, Yahya; Forbes, Andrew B.; Arabi, Yaseen; Bass, Frances; Bellomo, Rinaldo; Kadiman, Suhaini; Howe, Belinda D.; McArthur, Colin; Reade, Michael C.; Seppelt, Ian; Takala, Jukka; Webb, Steve; Wise, Matthew P.; for the SPICE III study investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre.

In: Critical Care and Resuscitation, Vol. 19, No. 4, 01.12.2017, p. 318-326.

Research output: Contribution to journalArticleOtherpeer-review

TY - JOUR

T1 - The SPICE III study protocol and analysis plan

T2 - a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients (Protocol)

AU - Shehabi, Yahya

AU - Forbes, Andrew B.

AU - Arabi, Yaseen

AU - Bass, Frances

AU - Bellomo, Rinaldo

AU - Kadiman, Suhaini

AU - Howe, Belinda D.

AU - McArthur, Colin

AU - Reade, Michael C.

AU - Seppelt, Ian

AU - Takala, Jukka

AU - Webb, Steve

AU - Wise, Matthew P.

AU - for the SPICE III study investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre

PY - 2017/12/1

Y1 - 2017/12/1

N2 - BACKGROUND: Sedation strategy in critically ill patients who are mechanically ventilated is influenced by patient-related factors, choice of sedative agent and the intensity or depth of sedation prescribed. The impact of sedation strategy on outcome, in particular when delivered early after initiation of mechanical ventilation, is uncertain. OBJECTIVES: To present the protocol and analysis plan of a large randomised clinical trial investigating the effect of a sedation strategy, in critically ill patients who are mechanically ventilated, based on a protocol targeting light sedation using dexmedetomidine as the primary sedative, termed "early goal-directed sedation", compared with usual practice. METHODS: This is a multinational randomised clinical trial in adult intensive care patients expected to require mechanical ventilation for longer than 24 hours. The main exclusion criteria include suspected or proven primary brain pathology or having already been intubated or sedated in an intensive care unit for longer than 12 hours. Randomisation occurs via a secured website with baseline stratification by site and suspected or proven sepsis. The primary outcome is 90-day all-cause mortality. Secondary outcomes include death, institutional dependency, cognitive function and health-related quality of life 180 days after randomisation, as well as delirium free, coma-free and ventilation-free days at 28 days after randomisation. A predefined subgroup analysis will also be conducted. Analyses will be on an intention-to-treat basis and in accordance with this pre-specified analysis plan. CONCLUSION: SPICE III is an ongoing large scale clinical trial. Once completed, it will inform sedation practice in critically ill patients who are ventilated.

AB - BACKGROUND: Sedation strategy in critically ill patients who are mechanically ventilated is influenced by patient-related factors, choice of sedative agent and the intensity or depth of sedation prescribed. The impact of sedation strategy on outcome, in particular when delivered early after initiation of mechanical ventilation, is uncertain. OBJECTIVES: To present the protocol and analysis plan of a large randomised clinical trial investigating the effect of a sedation strategy, in critically ill patients who are mechanically ventilated, based on a protocol targeting light sedation using dexmedetomidine as the primary sedative, termed "early goal-directed sedation", compared with usual practice. METHODS: This is a multinational randomised clinical trial in adult intensive care patients expected to require mechanical ventilation for longer than 24 hours. The main exclusion criteria include suspected or proven primary brain pathology or having already been intubated or sedated in an intensive care unit for longer than 12 hours. Randomisation occurs via a secured website with baseline stratification by site and suspected or proven sepsis. The primary outcome is 90-day all-cause mortality. Secondary outcomes include death, institutional dependency, cognitive function and health-related quality of life 180 days after randomisation, as well as delirium free, coma-free and ventilation-free days at 28 days after randomisation. A predefined subgroup analysis will also be conducted. Analyses will be on an intention-to-treat basis and in accordance with this pre-specified analysis plan. CONCLUSION: SPICE III is an ongoing large scale clinical trial. Once completed, it will inform sedation practice in critically ill patients who are ventilated.

UR - http://www.scopus.com/inward/record.url?scp=85040024031&partnerID=8YFLogxK

M3 - Article

VL - 19

SP - 318

EP - 326

JO - Critical Care and Resuscitation

JF - Critical Care and Resuscitation

SN - 1441-2772

IS - 4

ER -