Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients (SPICE III RCT)
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ClinicalTrials.gov Identifier: NCT01728558 |
Recruitment Status :
Completed
First Posted : November 20, 2012
Last Update Posted : August 20, 2019
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Tracking Information | ||||||||||||||||||||||||||||||||||||||||
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First Submitted Date ICMJE | November 4, 2012 | |||||||||||||||||||||||||||||||||||||||
First Posted Date ICMJE | November 20, 2012 | |||||||||||||||||||||||||||||||||||||||
Last Update Posted Date | August 20, 2019 | |||||||||||||||||||||||||||||||||||||||
Actual Study Start Date ICMJE | November 2013 | |||||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | August 2018 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Mortality [ Time Frame: Day 90 post randomisation ] | |||||||||||||||||||||||||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||
Change History | ||||||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||||||||||||||||||||
Brief Title ICMJE | Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients | |||||||||||||||||||||||||||||||||||||||
Official Title ICMJE | Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients: a Prospective Multicentre Randomised Controlled Trial | |||||||||||||||||||||||||||||||||||||||
Brief Summary | The Use of sedative drugs in intensive care is widespread. A cohort study conducted in Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the first 48 hours of mechanical ventilation which was independently linked to prolonged ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009) supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens ventilation time and attenuates delirium when compared to midazolam and propofol. The investigators confirmed in a pilot study the feasibility, efficacy and safety of a process of care known as Early Goal Directed Sedation (EGDS) that delivers:
The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients. The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care sedation, reduces 90-day all-cause mortality in critically ill patients who require mechanical ventilation. |
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Detailed Description | This is a large-scale study into the effectiveness of a novel approach for sedation in ventilated critically ill patients. The primary aim of this study is to determine whether Early Goal Directed Sedation therapy, compared to standard care sedation, reduces 90-day mortality in critically ill patients ventilated > 24 hrs. The study will be a randomized, unblinded, controlled trial conducted in approximately 35-50 intensive care units (ICUs) and will recruit 4000 mechanically ventilated patients (life support) who are expected to remain on the ventilator > 24 hours AND require immediate ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures, including mechanical ventilation. Patients with primary brain injury or prolonged weakness are excluded. Participants will be randomized into one of 2 study groups. All patients will receive adequate analgesia at randomization at the discretion of treating clinician. All randomized patients will have Light sedation as the default target unless otherwise clinically indicated. The intervention group will receive EGDS with dexmedetomidine as the primary sedative agent to achieve light sedation, with the addition of propofol as required. The use of benzodiazepines in the intervention group is not allowed, with the exception of specific, defined circumstances. The control group will have sedation according to usual practice as chosen by the treating clinician. The use of dexmedetomidine is not allowed, with the exception of specific, defined circumstances. Deidentified data will be collected and will include; Baseline demographic information; Doses of all sedative, analgesic and other related medications; Pain, sedation and delirium scores and major treatments such as ventilation time, tracheostomy and dialysis. Patients surviving to hospital discharge will be contacted by phone to determine independent survival status at 90 days and again at 180 days plus Health Related Quality of Life and cognitive function assessment. |
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Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Critical Illness and Mechanical Ventilation | |||||||||||||||||||||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||||||||||||||||||||
Actual Enrollment ICMJE |
4000 | |||||||||||||||||||||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||
Actual Study Completion Date ICMJE | December 2018 | |||||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | August 2018 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||||||||||||||||||||
Listed Location Countries ICMJE | Australia, Ireland, Italy, Malaysia, New Zealand, Saudi Arabia, Switzerland, United Kingdom | |||||||||||||||||||||||||||||||||||||||
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Administrative Information | ||||||||||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT01728558 | |||||||||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | ANZIC-RC/YS003 | |||||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Yes | |||||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||||||||||||||
Current Responsible Party | Australian and New Zealand Intensive Care Research Centre | |||||||||||||||||||||||||||||||||||||||
Original Responsible Party | Yahya Shehabi, Australian and New Zealand Intensive Care Research Centre, Associate Professor | |||||||||||||||||||||||||||||||||||||||
Current Study Sponsor ICMJE | Australian and New Zealand Intensive Care Research Centre | |||||||||||||||||||||||||||||||||||||||
Original Study Sponsor ICMJE | Yahya Shehabi | |||||||||||||||||||||||||||||||||||||||
Collaborators ICMJE | National Health and Medical Research Council, Australia | |||||||||||||||||||||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Australian and New Zealand Intensive Care Research Centre | |||||||||||||||||||||||||||||||||||||||
Verification Date | April 2019 | |||||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |