ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock

PHASE4CompletedINTERVENTIONAL
Enrollment

3,800

Participants

Timeline

Start Date

June 13, 2012

Primary Completion Date

October 22, 2017

Study Completion Date

November 20, 2017

Conditions
Septic Shock
Interventions
DRUG

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.

DRUG

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"

Trial Locations (70)

1142

Auckland City Hospital (CVICU), Auckland

Auckland City Hospital (DCCM), Auckland

1640

Middlemore Hospital, Auckland

1871

Liverpool Hospital, Liverpool

2000

The George Institute for Global Health, Sydney

2010

St Vincent's Hospital, Darlinghurst

2031

Prince of Wales Hospital, Randwick

2050

Royal Prince Alfred Hospital, Camperdown

2065

Royal North Shore Hospital, St Leonards

2100

Rigshospitalet, Copenhagen

2148

Blacktown Hospital, Blacktown

2217

St George Hospital, Kogarah

2250

Gosford Hospital, Gosford

2298

Calvary Mater Hospital (Newcastle), Waratah

2305

John Hunter Hospital, Newcastle

2340

Tamworth Rural Referral Hospital, Tamworth

2485

Tweed Heads District Hospital, Tweed Heads

2521

Wollongong Hospital, Wollongong

2747

Nepean Hospital, Penrith

3011

Footscray Hospital, Footscray

3021

Sunshine Hospital, St Albans

3050

Royal Melbourne Hospital, Parkville

3065

St Vincent's Hospital (Melbourne), Fitzroy

3076

Northern Hospital, Epping

3084

Austin Hospital, Heidelberg

3110

Tauranga Hospital, Tauranga

3168

Monash Medical Centre, Clayton

3220

Geelong Hospital (Barwon Health), Geelong

3240

Waikato Hospital, Hamilton

3550

Bendigo Hospital, Bendigo

4020

Redcliffe Hospital, Redcliffe

4029

Royal Brisbane and Women's Hospital, Herston

4032

Prince Charles Hospital, Brisbane

4066

Wesley Hospital, Auchenflower

4101

Mater Health Services, Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4131

Logan Hospital, Logan City

4215

Gold Coast University Hospital, Gold Coast

4307

Ipswich Hospital, Ipswich

4350

Toowoomba Hospital, Toowoomba

4560

Nambour Hospital, Nambour

4740

Mackay Base Hospital, Mackay

4814

Townsville Hospital, Townsville

5000

Royal Adelaide Hospital, Adelaide

5011

The Queen Elizabeth Hospital, Woodville South

5112

Lyell McEwin Hospital, Elizabeth Vale

6000

Royal Perth Hospital, Perth

6011

Wellington Hospital, Wellington

6150

Fiona Stanley Hospital, Murdoch

St John of God Hospital-Murdoch, Perth

6959

Fremantle Hospital, Fremantle

7000

Royal Hobart Hospital, Hobart

8011

Christchurch Hospital, Christchurch

11426

King Abdulaziz Medical City, Riyadh

11472

King Khalid University Hospital, King Saud University, Riyadh

11525

King Fahad Medical City, Riyadh

0810

Royal Darwin Hospital, Darwin

0622

North Shore Hospital, North Shore

BS2 8HW

Bristol Royal Infirmary, Bristol

KT16 0PZ

Ashford & St.Peter's NHS Foundation Trust, Chertsey

PO63LY

Queen Alexandra Hospital (Portsmouth), Cosham

B15 2TH

Queen Elizabeth Hospital Birmingham, Edgbaston

GU2 7XX

Royal Surrey County Hospital, Guildford

SE 13 6LH

Lewisham Healthcare NHS Trust, London

SE1 9RT

Guy's and St Thomas' HNS Foundation Trust, London

SE5 9RS

King's College Hospital NHS Foundation Trust, London

SW17 0QH

St Georges Healthcare NHS Trust, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

S016 6YD

University Hospital Southampton, Southampton

NP20 2UB

Royal Gwent Hospital, Newport

All Listed Sponsors
collaborator

National Health and Medical Research Council, Australia

OTHER

collaborator

Australian and New Zealand Intensive Care Society Clinical Trials Group

NETWORK

lead

The George Institute

OTHER

NCT01448109 - ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock | Biotech Hunter | Biotech Hunter