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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01448109
Registration number
NCT01448109
Ethics application status
Date submitted
5/10/2011
Date registered
7/10/2011
Date last updated
12/12/2017
Titles & IDs
Public title
ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock
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Scientific title
A Randomised Blinded Placebo Controlled Trial of Hydrocortisone in Critically Ill Patients With Septic Shock
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Secondary ID [1]
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GI-CCT372273
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Universal Trial Number (UTN)
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Trial acronym
ADRENAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Septic Shock
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Hydrocortisone
Treatment: Drugs - Sterile air filled vial
Active comparator: Hydrocortisone -
Placebo comparator: Sterile air filled vial -
Treatment: Drugs: Hydrocortisone
Hydrocortisone 100mg vial (blinded) is reconstituted with 2ml of water for Injection, agitated for 20 seconds, rested for 3 minutes, contents of vial aspirated and added to 100ml bag of normal saline or 5% dextrose and given intravenously as a continuous infusion at rate of 200mg/per day for 7 days.
Treatment: Drugs: Sterile air filled vial
the "sterile air filled vial" (blinded) is reconstituted with 2ml of water for Injection, agitated for 20 seconds, rested for 3 minutes, contents of vial aspirated and added to 100ml bag of normal saline or 5% dextrose and given intravenously as a continuous infusion. 2 sterile air filled vials per day for 7 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All cause mortality at 90 days after randomisation
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Assessment method [1]
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Timepoint [1]
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90 days after randomisation
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Secondary outcome [1]
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All-cause mortality at 28 days and 6 months after randomisation
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Assessment method [1]
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Timepoint [1]
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28 days and 6 months after randomisation
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Secondary outcome [2]
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Time to resolution of shock
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Assessment method [2]
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Time to resolution of shock - defined as "the time taken to achieve a clinician prescribed mean arterial pressure (MAP) goal for \>24 hours without vasopressors or inotropes.
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Timepoint [2]
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MAP goal for >24 hours without vasopressors or inotropes. Up to 90 days after randomisation.
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Secondary outcome [3]
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Recurrence of shock
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Assessment method [3]
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Recurrence of shock - defined as a new episode of shock after reversal of the initial episode.
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Timepoint [3]
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Up to90 days after randomisation
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Secondary outcome [4]
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Duration of ICU stay
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Assessment method [4]
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Timepoint [4]
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Up to 90 days after randomisation
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Secondary outcome [5]
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Duration of hospital stay
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Assessment method [5]
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Timepoint [5]
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Up to 90 days after randomisation
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Secondary outcome [6]
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Frequency and duration of mechanical ventilation
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Assessment method [6]
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Timepoint [6]
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Up to 90 days after randomisation
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Secondary outcome [7]
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Duration of renal replacement therapy
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Assessment method [7]
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Timepoint [7]
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Up to 90 days after randomisation
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Secondary outcome [8]
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Development of bacteraemia
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Assessment method [8]
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Timepoint [8]
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2 and 14 days post randomisation
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Secondary outcome [9]
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Bleeding requiring blood transfusions received in the ICU
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Assessment method [9]
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Timepoint [9]
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Up to 90 days after randomisation
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Secondary outcome [10]
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Quality of Life assessment at 6 months.
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Assessment method [10]
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Timepoint [10]
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6 months.
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Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Documented site of infection, or strong suspicion of infection, with 2 of the 4 clinical signs of inflammation:
* Core temperature > 38°C or < 35°C
* Heart rate > 90 beats per minute
* White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils
* Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation.
3. Being treated with mechanical ventilation at the time of randomisation
4. Being treated with vasopressors or inotropes to maintain a systolic blood pressure > 90mmHg, or mean arterial blood pressure > 60mmHg, or a MAP target set by the treating clinician for maintaining perfusion
5. Administration of vasopressors or inotropes for = 4 hours and present at time of randomisation.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Met all inclusion criteria more than 24 hours ago
2. Clinician expects to prescribe systemic corticosteroids for an indication other than septic shock (not including nebulised or inhaled corticosteroid)
3. Patients treated with etomidate
4. Patients receiving treatment with Amphotericin B for systemic fungal infections at time of randomisation
5. Patients with documented cerebral malaria at the time of randomisation
6. Patients with documented strongyloides infection at the time of randomisation
7. Death is deemed inevitable or imminent during this admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment
8. Death from underlying disease is likely within 90 days
9. Patient has been previously enrolled in the ADRENAL study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/11/2017
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Sample size
Target
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Accrual to date
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Final
3800
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
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Blacktown Hospital - Blacktown
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Royal Prince Alfred Hospital - Camperdown
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St Vincent's Hospital - Darlinghurst
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Gosford Hospital - Gosford
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St George Hospital - Kogarah
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Liverpool Hospital - Liverpool
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John Hunter Hospital - Newcastle
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Nepean Hospital - Penrith
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Prince of Wales Hospital - Randwick
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Royal North Shore Hospital - St Leonards
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The George Institute for Global Health - Sydney
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Tamworth Rural Referral Hospital - Tamworth
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Tweed Heads District Hospital - Tweed Heads
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Calvary Mater Hospital (Newcastle) - Waratah
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Wollongong Hospital - Wollongong
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Royal Darwin Hospital - Darwin
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Wesley Hospital - Auchenflower
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Prince Charles Hospital - Brisbane
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Mater Health Services - Brisbane
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Gold Coast University Hospital - Gold Coast
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Royal Brisbane and Women's Hospital - Herston
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Ipswich Hospital - Ipswich
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Logan Hospital - Logan
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Mackay Base Hospital - Mackay
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Nambour Hospital - Nambour
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Redcliffe Hospital - Redcliffe
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Townsville Hospital - Townsville
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Lyell McEwin Hospital - Elizabeth Vale
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The Queen Elizabeth Hospital - Woodville South
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Royal Hobart Hospital - Hobart
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Bendigo Hospital - Bendigo
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Monash Medical Centre - Clayton
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Northern Hospital - Epping
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St Vincent's Hospital (Melbourne) - Fitzroy
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Footscray Hospital - Footscray
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Geelong Hospital (Barwon Health) - Geelong
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Austin Hospital - Heidelberg
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Royal Melbourne Hospital - Parkville
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Sunshine Hospital - St Albans
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Fremantle Hospital - Fremantle
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Fiona Stanley Hospital - Murdoch
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Royal Perth Hospital - Perth
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St John of God Hospital-Murdoch - Perth
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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2250 - Gosford
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2217 - Kogarah
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1871 - Liverpool
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2305 - Newcastle
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2747 - Penrith
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2031 - Randwick
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2065 - St Leonards
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2000 - Sydney
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2340 - Tamworth
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2485 - Tweed Heads
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Recruitment postcode(s) [14]
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2298 - Waratah
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2521 - Wollongong
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Recruitment postcode(s) [16]
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0810 - Darwin
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4066 - Auchenflower
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4032 - Brisbane
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Recruitment postcode(s) [19]
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4101 - Brisbane
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4215 - Gold Coast
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Recruitment postcode(s) [21]
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4029 - Herston
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4307 - Ipswich
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Recruitment postcode(s) [23]
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4131 - Logan
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4740 - Mackay
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4560 - Nambour
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4020 - Redcliffe
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4350 - Toowoomba
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4814 - Townsville
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4102 - Woolloongabba
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Recruitment postcode(s) [30]
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5000 - Adelaide
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Recruitment postcode(s) [31]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [32]
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5011 - Woodville South
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Recruitment postcode(s) [33]
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7000 - Hobart
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Recruitment postcode(s) [34]
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3550 - Bendigo
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Recruitment postcode(s) [35]
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3168 - Clayton
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Recruitment postcode(s) [36]
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3076 - Epping
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3065 - Fitzroy
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Recruitment postcode(s) [38]
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3011 - Footscray
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Recruitment postcode(s) [39]
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3220 - Geelong
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Recruitment postcode(s) [40]
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3084 - Heidelberg
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Recruitment postcode(s) [41]
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3050 - Parkville
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Recruitment postcode(s) [42]
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3021 - St Albans
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Recruitment postcode(s) [43]
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6959 - Fremantle
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Recruitment postcode(s) [44]
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6150 - Murdoch
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6000 - Perth
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Recruitment postcode(s) [46]
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6150 - Perth
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Recruitment outside Australia
Country [1]
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Denmark
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Copenhagen
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New Zealand
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Auckland
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New Zealand
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NZ
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New Zealand
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Christchurch
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New Zealand
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Tauranga
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New Zealand
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Wellington
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Saudi Arabia
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Riyadh
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United Kingdom
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England
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United Kingdom
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State/province [9]
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Wales
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australian and New Zealand Intensive Care Society Clinical Trials Group
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to find out whether adult patients admitted to the Intensive Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy solution), will have an improved rate of survival 90 days later. Septic shock is the result of an infection, which triggers a complex response by the body (the inflammatory response) that causes a decrease in blood pressure and subsequently one or more organ systems to fail when blood supply to these organs is reduced. This may result in poor recovery and death. About a quarter of the people who suffer septic shock that is not rapidly reversed, will die. When patients are admitted to Intensive Care with sepsis and/or septic shock they receive a number of therapies. These include fluids given through a drip, antibiotics, drugs to boost your blood pressure and other organ systems. In addition to these therapies, steroids (hydrocortisone) are sometimes administered. Whether steroids are useful or not in the treatment of severe infections has been studied for more than 50 years. Previous research has suggested that the use of low dose steroid may have shortterm benefits in improving the circulation. However, there is no agreement amongst doctors around the world about whether treatment with or without low dose steroids improves the overall recovery and survival in patients with septic shock. This study would allow doctors to make informed decisions about whether the addition of low dose steroid therapy is better for patients with septic shock in intensive care. The study will include 3800 intensive care patients who have septic shock. Each enrolled patient will be randomised to receive either Hydrocortisone 200mg or placebo daily for 7 days as a continuous intravenous infusion while in intensive care. The patient will be followed for 90 days. If the patient is discharged prior to 90 days a telephone call will be made for the followup information. At six months the patient will be contacted again for completion of a quality of life questionnaire.
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Trial website
https://clinicaltrials.gov/study/NCT01448109
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Trial related presentations / publications
Venkatesh B, Finfer S, Cohen J, Rajbhandari D, Arabi Y, Bellomo R, Billot L, Correa M, Glass P, Harward M, Joyce C, Li Q, McArthur C, Perner A, Rhodes A, Thompson K, Webb S, Myburgh J; ADRENAL Trial Investigators and the Australian-New Zealand Intensive Care Society Clinical Trials Group. Adjunctive Glucocorticoid Therapy in Patients with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):797-808. doi: 10.1056/NEJMoa1705835. Epub 2018 Jan 19.
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Public notes
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Contacts
Principal investigator
Name
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Balasubramanian Venkatesh
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Address
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The George Institute
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01448109
Download to PDF