ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock
NCT ID: NCT01448109
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
3800 participants
INTERVENTIONAL
2012-06-13
2017-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Corticosteroid Therapy of Septic Shock - Corticus
NCT00147004
Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
NCT01284452
Hydrocortisone for Prevention of Septic Shock
NCT00670254
Initiation of Hydrocortisone for the Treatment of Septic Shock
NCT02580240
Effects of Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
NCT02114710
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary Objectives To assess the impact of intravenous hydrocortisone versus placebo on the recovery from, and the complications of, septic shock and the development of treatment related adverse reactions.
Study Design This study is a multi centre, randomised, blinded, placebo controlled trial comparing intravenous hydrocortisone with placebo in critically ill patients with septic shock.
Randomisation will be achieved via a secure interactive web based system using permuted block minimisation. Randomisation will be stratified by participating site and by operative or non-operative admission to the ICU.
The primary endpoint for this trial will be death from all causes at 90 days.
Pre defined sub groups will include the following categories:
* Operative (admitted to ICU from operating theatre or recovery room) versus non-operative admission.
* Dose of adrenaline or noradrenaline at randomisation - ≤ 15 mcg / minute versus \> 15 mcg / minute.
3,800 patients will be enrolled in this study at approximately 50 - 60 study sites. Eligible patients will be randomised to receive either intravenous hydrocortisone 200mg or placebo per day for 7 days.
For all patients, data will be collected at baseline and then daily whilst the patient is in the ICU. Patients will be followed up to day 14, regardless of where the patient resides in the hospital, to monitor the development of bacteraemia. Additional follow up will occur at 90 days and at 6 months post randomisation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hydrocortisone
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.
Sterile air filled vial
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Health and Medical Research Council, Australia
OTHER
Australian and New Zealand Intensive Care Society Clinical Trials Group
NETWORK
The George Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Balasubramanian Venkatesh
Role: STUDY_CHAIR
The George Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Blacktown Hospital
Blacktown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
The George Institute for Global Health
Sydney, New South Wales, Australia
Tamworth Rural Referral Hospital
Tamworth, New South Wales, Australia
Tweed Heads District Hospital
Tweed Heads, New South Wales, Australia
Calvary Mater Hospital (Newcastle)
Waratah, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Darwin Hospital
Darwin, Northern Territory, Australia
Wesley Hospital
Auchenflower, Queensland, Australia
Prince Charles Hospital
Brisbane, Queensland, Australia
Mater Health Services
Brisbane, Queensland, Australia
Gold Coast University Hospital
Gold Coast, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Ipswich Hospital
Ipswich, Queensland, Australia
Logan Hospital
Logan City, Queensland, Australia
Mackay Base Hospital
Mackay, Queensland, Australia
Nambour Hospital
Nambour, Queensland, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Bendigo Hospital
Bendigo, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Northern Hospital
Epping, Victoria, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Footscray Hospital
Footscray, Victoria, Australia
Geelong Hospital (Barwon Health)
Geelong, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
St John of God Hospital-Murdoch
Perth, Western Australia, Australia
Rigshospitalet
Copenhagen, , Denmark
North Shore Hospital
North Shore, Auckland, New Zealand
Waikato Hospital
Hamilton, NZ, New Zealand
Auckland City Hospital (CVICU)
Auckland, , New Zealand
Auckland City Hospital (DCCM)
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Wellington Hospital
Wellington, , New Zealand
King Abdulaziz Medical City
Riyadh, , Saudi Arabia
King Khalid University Hospital, King Saud University
Riyadh, , Saudi Arabia
King Fahad Medical City
Riyadh, , Saudi Arabia
Bristol Royal Infirmary
Bristol, England, United Kingdom
Ashford & St.Peter's NHS Foundation Trust
Chertsey, England, United Kingdom
Queen Alexandra Hospital (Portsmouth)
Cosham, England, United Kingdom
Queen Elizabeth Hospital Birmingham
Edgbaston, England, United Kingdom
Royal Surrey County Hospital
Guildford, England, United Kingdom
Lewisham Healthcare NHS Trust
London, England, United Kingdom
Guy's and St Thomas' HNS Foundation Trust
London, England, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
St Georges Healthcare NHS Trust
London, England, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
University Hospital Southampton
Southampton, England, United Kingdom
Royal Gwent Hospital
Newport, Wales, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Daubney ER, D'Urso S, Cuellar-Partida G, Rajbhandari D, Peach E, de Guzman E, McArthur C, Rhodes A, Meyer J, Finfer S, Myburgh J, Cohen J, Schirra HJ, Venkatesh B, Evans DM. A Genome-Wide Association Study of Serum Metabolite Profiles in Septic Shock Patients. Crit Care Explor. 2024 Jan 17;6(1):e1030. doi: 10.1097/CCE.0000000000001030. eCollection 2024 Jan.
Li W, Cornelius V, Finfer S, Venkatesh B, Billot L. Adaptive designs in critical care trials: a simulation study. BMC Med Res Methodol. 2023 Oct 18;23(1):236. doi: 10.1186/s12874-023-02049-6.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GI-CCT372273
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.