Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-04 @ 12:10 AM
Study NCT ID:
NCT01728558
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2012-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-18', 'studyFirstSubmitDate': '2012-11-04', 'studyFirstSubmitQcDate': '2012-11-13', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Day 90 post randomisation'}], 'secondaryOutcomes': [{'measure': 'Ventilation free days', 'timeFrame': 'at 28 days following randomisation'}, {'measure': 'Proportion of RASS measurements in target range', 'timeFrame': 'up to day 28'}, {'measure': 'Incidence and duration of delirium measured by delirium free days', 'timeFrame': 'up to 28 days'}, {'measure': 'Length of ICU stay', 'timeFrame': 'up to 180 days'}, {'measure': 'Proportion of patients who receive a tracheostomy Proportion of patients who require: re-intubation, physical restraints,or unplanned extubation,', 'timeFrame': 'up to day 28'}, {'measure': 'Cumulative dose of midazolam, propofol, dexmedetomidine, fentanyl, and morphine', 'timeFrame': 'up to 28 days'}, {'measure': 'Duration of treatment with midazolam, propofol, dexmedetomidine, fentanyl, and morphine', 'timeFrame': 'up to 28 days'}, {'measure': 'Mortality at hospital discharge', 'timeFrame': 'at hospital discharge up to 180 days'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 180 days'}, {'measure': 'Readmission to ICU', 'timeFrame': 'at 90 days'}, {'measure': 'EQ-5D questionnaire', 'timeFrame': 'at 180 days'}, {'measure': 'Cognitive function', 'timeFrame': 'at 180 days'}, {'measure': 'Mortality at ICU discharge', 'timeFrame': 'up to 180 days'}, {'measure': 'Full time institutional dependency at 180 days', 'timeFrame': 'up to 180 days'}, {'measure': 'Discharge destination', 'timeFrame': 'up to 180 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sedation', 'Delirium', 'Goal Directed', 'Dexmedetomidine', 'Mortality', 'Mechanical ventilation', 'Intensive care', 'Critically Ill'], 'conditions': ['Critical Illness and Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '22859526', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36215171', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32678054', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31112380', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29926288', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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:\n\n1. Early randomization after intubation or arrival in the ICU (intubated).\n2. Early Adequate analgesia after randomization.\n3. Goal directed sedation titrated to achieve light sedation.\n4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines.\n\nThe aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nPatients 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.\n\nThe 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.\n\nDeidentified 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been intubated and is receiving mechanical ventilation\n* The treating clinician expects that the patient will remain intubated until the day after tomorrow (unlikely to be extubated the following day).\n* The patient requires immediate ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Patient is pregnant and/or lactating\n* Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours in an intensive care unit.\n* Proven or suspected acute primary brain lesion such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.\n* Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness.\n* Admission as a consequence of a suspected or proven drug overdose or burns.\n* Administration of ongoing neuromuscular blockade.\n* A mean arterial blood (MAP) pressure that is less than 50 mmHg despite adequate resuscitation and vasopressor therapy at time of randomisation\n* 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.\n* Known sensitivity to any of the study medications or the constituents of propofol (egg, soya or peanut protein)\n* Acute fulminant hepatic failure\n* Patient has been receiving full time residential nursing care.\n* 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.\n* Patient has an underlying disease that makes survival to 90 days unlikely\n* Patient has been previously enrolled in the SPICE study.'}, 'identificationModule': {'nctId': 'NCT01728558', 'acronym': 'SPICE III RCT', 'briefTitle': 'Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Australian and New Zealand Intensive Care Research Centre'}, 'officialTitle': 'Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients: a Prospective Multicentre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'ANZIC-RC/YS003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Early Goal Directed Sedation', 'description': 'Early Goal Directed Sedation process of care involves:\n\n1. Early delivery of proposed intervention, shortly after initiating mechanical ventilation;\n2. Effective analgesia provided simultaneously and early (analgesia first).\n3. Regular and frequent assessment of patient wakefulness/sedative state;\n4. Avoidance of benzodiazepines and minimisation of use of propofol;\n5. 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.\n\nDexmedetomidine infusion will be continued until sedation is no longer clinically indicated up to a maximum of 28 days after enrolment.', 'interventionNames': ['Other: Early goal Directed Sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care Sedation Arm', 'description': '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.', 'interventionNames': ['Other: Standard care sedation']}], 'interventions': [{'name': 'Early goal Directed Sedation', 'type': 'OTHER', 'armGroupLabels': ['Early Goal Directed Sedation']}, {'name': 'Standard care sedation', 'type': 'OTHER', 'armGroupLabels': ['Standard care Sedation Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2640', 'city': 'Albury', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Albury Hospital', 'geoPoint': {'lat': -36.07482, 'lon': 146.92401}}, {'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Blacktown Hospital', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2250', 'city': 'Gosford', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Gosford Hospital', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'zip': '2077', 'city': 'Hornsby', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Hornsby Ku-ring-gai Hospital', 'geoPoint': {'lat': -33.70244, 'lon': 151.09931}}, {'zip': '2750', 'city': 'Penrith', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Nepean Hospital', 'geoPoint': {'lat': -33.75, 'lon': 150.7}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '0811', 'city': 'Tiwi', 'state': 'Northern Territory', 'country': 'Australia', 'facility': 'Royal Darwin Hospital', 'geoPoint': {'lat': -12.35876, 'lon': 130.878}}, {'zip': '4556', 'city': 'Buderim', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Sunshine Coast Hospital (Nambour Hospital)', 'geoPoint': {'lat': -26.68443, 'lon': 153.05705}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4020', 'city': 'Redcliffe', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Redcliffe Hospital', 'geoPoint': {'lat': -27.22649, 'lon': 153.10648}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast Hospital & Health Service', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4350', 'city': 'Toowoomba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Toowoomba Hospital', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5112', 'city': 'Elizabeth Vale', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Lyell McEwan Hospital', 'geoPoint': {'lat': -34.74857, 'lon': 138.66819}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '7250', 'city': 'Launceston', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Launceston General Hospital', 'geoPoint': {'lat': -41.43876, 'lon': 147.13467}}, {'zip': '3550', 'city': 'Bendigo', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Bendigo Hospital', 'geoPoint': {'lat': -36.75818, 'lon': 144.28024}}, {'zip': '3175', 'city': 'Dandenong', 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'Victoria', 'country': 'Australia', 'facility': 'Central Gippsland Health Service', 'geoPoint': {'lat': -38.11095, 'lon': 147.06802}}, {'zip': '3152', 'city': 'Wantirna', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Knox Private Hospital', 'geoPoint': {'lat': -37.85, 'lon': 145.21667}}, {'zip': '6008', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'St John Of God, Subiaco', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Dublin', 'state': 'Dublin 4', 'country': 'Ireland', 'facility': "St Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'state': 'Dublin 8', 'country': 'Ireland', 'facility': "St James's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '15200', 'city': 'Kota Bharu', 'state': 'Kelantan', 'country': 'Malaysia', 'facility': 'Raja Perempuan Zainab II Hospital', 'geoPoint': {'lat': 6.12361, 'lon': 102.24333}}, {'zip': '16150', 'city': 'Kota Bharu', 'state': 'Kelantan', 'country': 'Malaysia', 'facility': 'Universiti Sains Malaysia Hospital', 'geoPoint': {'lat': 6.12361, 'lon': 102.24333}}, {'zip': '10990', 'city': 'George Town', 'state': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Penang General Hospital', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}, {'zip': '88200', 'city': 'Kota Kinabalu', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}, {'zip': '93586', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Sarawak General Hospital', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '50400', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Institut Jantung Negara', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '50586', 'city': 'Kuala 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Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.41667, 'lon': -4.13333}}, {'zip': 'TS19 8PE', 'city': 'Hardwick', 'state': 'Stockton-on-Tees', 'country': 'United Kingdom', 'facility': 'University Hospital of North Tees', 'geoPoint': {'lat': 52.46032, 'lon': 1.26746}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital, Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BS1 3NU', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospital of Coventry and Warwick', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DT1 2JY', 'city': 'Dorchester', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St Thomas Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St 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New South Wales, Prince of Wales Hospital, ANZIC-RC'}, {'name': 'Rinaldo Bellomo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ANZIC-RC & Austin Hospital'}, {'name': 'Steve A. 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