Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients
NCT ID: NCT01728558
Last Updated: 2019-08-20
Study Results
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Basic Information
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COMPLETED
PHASE3
4000 participants
INTERVENTIONAL
2013-11-30
2018-12-31
Brief Summary
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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:
1. Early randomization after intubation or arrival in the ICU (intubated).
2. Early Adequate analgesia after randomization.
3. Goal directed sedation titrated to achieve light sedation.
4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines.
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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early Goal Directed Sedation
Early Goal Directed Sedation process of care involves:
1. Early delivery of proposed intervention, shortly after initiating mechanical ventilation;
2. Effective analgesia provided simultaneously and early (analgesia first).
3. Regular and frequent assessment of patient wakefulness/sedative state;
4. Avoidance of benzodiazepines and minimisation of use of propofol;
5. Reduced overall sedation depth with targeted light sedation; Patients randomised to the EGDS arm will receive a sedative infusion of Dexmedetomidine withor without minimal propofol in order to maintain a RASS of -2 to +1.
Dexmedetomidine infusion will be continued until sedation is no longer clinically indicated up to a maximum of 28 days after enrolment.
Early goal Directed Sedation
Standard care Sedation Arm
Patients randomised to the standard care sedation arm will receive process of care sedation directed by the treating clinician. Based on the information from our observational study and the EGDS Pilot trial, most patients in this group are likely to receive midazolam and /or propofol. These agents will be infused to achieve the default target of Light sedation (RASS -2 to +1) whenever clinically appropriate and as specified by the treating clinician. The use remifentanil or dexmedetomidine for initial and maintenance sedation will be precluded.
Standard care sedation
Interventions
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Early goal Directed Sedation
Standard care sedation
Eligibility Criteria
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Inclusion Criteria
* The treating clinician expects that the patient will remain intubated until the day after tomorrow (unlikely to be extubated the following day).
* The patient requires immediate ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.
Exclusion Criteria
* Patient is pregnant and/or lactating
* Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours in an intensive care unit.
* Proven or suspected acute primary brain lesion such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
* Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness.
* Admission as a consequence of a suspected or proven drug overdose or burns.
* Administration of ongoing neuromuscular blockade.
* A mean arterial blood (MAP) pressure that is less than 50 mmHg despite adequate resuscitation and vasopressor therapy at time of randomisation
* Heart rate less than 55 beats per minute unless the patient is being treated with a beta-blocker or a high grade atrio-ventricular block in the absence of a functioning pacemaker.
* Known sensitivity to any of the study medications or the constituents of propofol (egg, soya or peanut protein)
* Acute fulminant hepatic failure
* Patient has been receiving full time residential nursing care.
* Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment.
* Patient has an underlying disease that makes survival to 90 days unlikely
* Patient has been previously enrolled in the SPICE study.
18 Years
ALL
No
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Australian and New Zealand Intensive Care Research Centre
OTHER
Responsible Party
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Principal Investigators
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Yahya Shehabi, MD, FCICM, FANZCA, EMBA
Role: STUDY_CHAIR
University New South Wales, Prince of Wales Hospital, ANZIC-RC
Rinaldo Bellomo
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC & Austin Hospital
Steve A. R Webb
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC & Royal Perth Hospital
Michael C Reade
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC, Royal Brisbane & Women's Hospital, Department of Military Medicine and Surgery,
Belinda D Howe
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC
Ian M Seppelt
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC, Nepean Hospital
Colin McArthur
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC, Auckland Hospital
Simon Erikson
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC,
Lynne Murray
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC
Suhaini Kadiman
Role: PRINCIPAL_INVESTIGATOR
Institut Jantung Negara, Malaysia
Jukka Takala
Role: PRINCIPAL_INVESTIGATOR
Inselspital, Bern, Switzerland
Yaseen Arabi
Role: PRINCIPAL_INVESTIGATOR
King Abdulaziz Medical Centre, KSA
Matthew P Wise
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Wales, UK
Locations
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Albury Hospital
Albury, New South Wales, Australia
Blacktown Hospital
Blacktown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Hornsby Ku-ring-gai Hospital
Hornsby, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Darwin Hospital
Tiwi, Northern Territory, Australia
Sunshine Coast Hospital (Nambour Hospital)
Buderim, Queensland, Australia
Royal Brisbane and Women's hospital
Herston, Queensland, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Gold Coast Hospital & Health Service
Southport, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Lyell McEwan Hospital
Elizabeth Vale, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Bendigo Hospital
Bendigo, Victoria, Australia
Dandenong Hospital
Dandenong, Victoria, Australia
Northern Hospital
Epping, Victoria, Australia
Geelong Hospital
Geelong, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Central Gippsland Health Service
Sale, Victoria, Australia
Knox Private Hospital
Wantirna, Victoria, Australia
St John Of God, Subiaco
Perth, Western Australia, Australia
St Vincent's University Hospital
Dublin, Dublin 4, Ireland
St James's University Hospital
Dublin, Dublin 8, Ireland
Ospedale San Raffaele
Milan, , Italy
Raja Perempuan Zainab II Hospital
Kota Bharu, Kelantan, Malaysia
Universiti Sains Malaysia Hospital
Kota Bharu, Kelantan, Malaysia
Penang General Hospital
George Town, Pulau Pinang, Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, Sabah, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Institut Jantung Negara
Kuala Lumpur, , Malaysia
Kuala Lumpar General Hospital
Kuala Lumpur, , Malaysia
University Malaya Medical Center
Kuala Lumpur, , Malaysia
Melaka General Hospital
Malacca, , Malaysia
Auckland City Hospital CVICU
Grafton, Auckland, New Zealand
Middlemore Hospital
Otahuhu, Auckland, New Zealand
Christchurch Hospital
Addington, Christchurch, New Zealand
North Shore Hospital
Takapuna, North Shore City, New Zealand
Wellington Hospital
Newtown, Wellington Region, New Zealand
Auckland City hospital
Auckland, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Rotorua Hospital
Rotorua, , New Zealand
Prince Sultan Military Medical City
Riyadh, , Saudi Arabia
King Saud Medical City
Riyadh, , Saudi Arabia
King Abdulaziz Medical City
Riyadh, , Saudi Arabia
Inselspital University Hospital Bern
Bern, , Switzerland
Kings College Hospital
Brixton, London, United Kingdom
Freeman Hospital
High Heaton, Newcastle Upon Tyne, United Kingdom
Queen Elizabeth Hospital King's Lynn
Kings Lynn, Norfolk, United Kingdom
Derriford Hospital
Crownhill, Plymouth, United Kingdom
University Hospital of North Tees
Hardwick, Stockton-on-Tees, United Kingdom
Queen Elizabeth Hospital, Birmingham
Birmingham, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
University Hospitals Bristol
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
University Hospital of Coventry and Warwick
Coventry, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
St Thomas Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Altnagelvin Hospital
Londonderry, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Princess Royal University Hospital
Orpington, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Countries
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References
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Shehabi Y, Bellomo R, Reade MC, Bailey M, Bass F, Howe B, McArthur C, Seppelt IM, Webb S, Weisbrodt L; Sedation Practice in Intensive Care Evaluation (SPICE) Study Investigators; ANZICS Clinical Trials Group. Early intensive care sedation predicts long-term mortality in ventilated critically ill patients. Am J Respir Crit Care Med. 2012 Oct 15;186(8):724-31. doi: 10.1164/rccm.201203-0522OC. Epub 2012 Aug 2.
Shehabi Y, Serpa Neto A, Bellomo R, Howe BD, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; SPICE III Study Investigators. Dexmedetomidine and Propofol Sedation in Critically Ill Patients and Dose-associated 90-Day Mortality: A Secondary Cohort Analysis of a Randomized Controlled Trial (SPICE III). Am J Respir Crit Care Med. 2023 Apr 1;207(7):876-886. doi: 10.1164/rccm.202206-1208OC.
Cioccari L, Luethi N, Bailey M, Shehabi Y, Howe B, Messmer AS, Proimos HK, Peck L, Young H, Eastwood GM, Merz TM, Takala J, Jakob SM, Bellomo R; ANZICS Clinical Trials Group and the SPICE III Investigators. The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: a subgroup analysis of the Sedation Practice in Intensive Care Evaluation [SPICE III] Trial. Crit Care. 2020 Jul 16;24(1):441. doi: 10.1186/s13054-020-03115-x.
Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; ANZICS Clinical Trials Group and the SPICE III Investigators. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med. 2019 Jun 27;380(26):2506-2517. doi: 10.1056/NEJMoa1904710. Epub 2019 May 19.
Moore JPR, Anstey C, Murray L, Fraser JF, Singer M. Allostasis and sedation practices in intensive care evaluation: an observational pilot study. Intensive Care Med Exp. 2018 Jun 20;6(1):13. doi: 10.1186/s40635-018-0179-0.
Other Identifiers
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ANZIC-RC/YS003
Identifier Type: -
Identifier Source: org_study_id
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