Septic ShockPhase 4ADRENALNCT01448109
ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock
A Phase 4 study testing Hydrocortisone and Sterile air filled vial in people with Septic Shock, run by The George Institute at 70 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Hydrocortisone and Sterile air filled vial
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,800 participants
- Where
- 70 sitesin 5 countries
- Study dates
- 13 Jun 2012to 20 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- 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.
Show all 9Show fewer
- Being treated with mechanical ventilation at the time of randomisation
- 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
- Administration of vasopressors or inotropes for = 4 hours and present at time of randomisation.
Who cannot join
- Met all inclusion criteria more than 24 hours ago
- Clinician expects to prescribe systemic corticosteroids for an indication other than septic shock (not including nebulised or inhaled corticosteroid)
- Patients treated with etomidate
- Patients receiving treatment with Amphotericin B for systemic fungal infections at time of randomisation
- Patients with documented cerebral malaria at the time of randomisation
- Patients with documented strongyloides infection at the time of randomisation
Show all 9Show fewer
- 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
- Death from underlying disease is likely within 90 days
- Patient has been previously enrolled in the ADRENAL study.
Trial locations and contacts
70 sites in 5 countries.
70 sites in 5 countries
Australia46 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Wesley Hospital
Auchenflower, Queensland, 4066
Bendigo Hospital
Bendigo, Victoria, 3550
Blacktown Hospital
Blacktown, New South Wales, 2148
Prince Charles Hospital
Brisbane, Queensland, 4032
Mater Health Services
Brisbane, Queensland, 4101
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
Royal Darwin Hospital
Darwin, Northern Territory, 0810
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Northern Hospital
Epping, Victoria, 3076
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065
Footscray Hospital
Footscray, Victoria, 3011
Fremantle Hospital
Fremantle, Western Australia, 6959
Geelong Hospital (Barwon Health)
Geelong, Victoria, 3220
Gold Coast University Hospital
Gold Coast, Queensland, 4215
Gosford Hospital
Gosford, New South Wales, 2250
Austin Hospital
Heidelberg, Victoria, 3084
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
Ipswich Hospital
Ipswich, Queensland, 4307
St George Hospital
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 1871
Logan Hospital
Logan City, Queensland, 4131
Mackay Base Hospital
Mackay, Queensland, 4740
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Nambour Hospital
Nambour, Queensland, 4560
John Hunter Hospital
Newcastle, New South Wales, 2305
Royal Melbourne Hospital
Parkville, Victoria, 3050
Nepean Hospital
Penrith, New South Wales, 2747
Royal Perth Hospital
Perth, Western Australia, 6000
St John of God Hospital-Murdoch
Perth, Western Australia, 6150
Prince of Wales Hospital
Randwick, New South Wales, 2031
Redcliffe Hospital
Redcliffe, Queensland, 4020
Sunshine Hospital
St Albans, Victoria, 3021
Royal North Shore Hospital
St Leonards, New South Wales, 2065
The George Institute for Global Health
Sydney, New South Wales, 2000
Tamworth Rural Referral Hospital
Tamworth, New South Wales, 2340
Toowoomba Hospital
Toowoomba, Queensland, 4350
Townsville Hospital
Townsville, Queensland, 4814
Tweed Heads District Hospital
Tweed Heads, New South Wales, 2485
Calvary Mater Hospital (Newcastle)
Waratah, New South Wales, 2298
Wollongong Hospital
Wollongong, New South Wales, 2521
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
United Kingdom12 sites
Bristol Royal Infirmary
Bristol, England, BS2 8HW
Ashford & St.Peter's NHS Foundation Trust
Chertsey, England, KT16 0PZ
Queen Alexandra Hospital (Portsmouth)
Cosham, England, PO63LY
Queen Elizabeth Hospital Birmingham
Edgbaston, England, B15 2TH
Royal Surrey County Hospital
Guildford, England, GU2 7XX
Lewisham Healthcare NHS Trust
London, England, SE 13 6LH
Guy's and St Thomas' HNS Foundation Trust
London, England, SE1 9RT
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS
St Georges Healthcare NHS Trust
London, England, SW17 0QH
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN
Royal Gwent Hospital
Newport, Wales, NP20 2UB
University Hospital Southampton
Southampton, England, S016 6YD
New Zealand8 sites
Auckland City Hospital (CVICU)
Auckland, 1142
Auckland City Hospital (DCCM)
Auckland, 1142
Middlemore Hospital
Auckland, 1640
Christchurch Hospital
Christchurch, 8011
Waikato Hospital
Hamilton, NZ, 3240
North Shore Hospital
North Shore, Auckland, 0622
Tauranga Hospital
Tauranga, 3110
Wellington Hospital
Wellington, 6011
Saudi Arabia3 sites
King Abdulaziz Medical City
Riyadh, 11426
King Khalid University Hospital, King Saud University
Riyadh, 11472
King Fahad Medical City
Riyadh, 11525
About this study
Official title: A Randomised Blinded Placebo Controlled Trial of Hydrocortisone in Critically Ill Patients With Septic Shock
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.
Read more
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.
Read the detailed description
Primary Objective To evaluate the impact of intravenous hydrocortisone versus placebo on all cause mortality at 90 days in critically ill patients with septic shock. The hypothesis is that hydrocortisone, compared to placebo, reduces 90-day all-cause mortality in patients admitted to an ICU with septic shock. 'Shock' is defined as the need for vasopressors or inotropes to maintain a systolic blood pressure > 90 millimetres of mercury (mmHg), or mean arterial blood pressure > 60mmHg or a mean arterial pressure (MAP) target set by the treating clinician for maintaining perfusion. 'Septic shock' is shock that is secondary to sepsis
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
- Septic Shock
- Being tested
- Hydrocortisone, Sterile air filled vial
- Keywords
- Sepsis, Corticosteroid
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Solu-Cortef
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 vialDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Active comparator | Not described Receives: Drug: Hydrocortisone |
| Sterile air filled vial | Placebo comparator | Not described Receives: Drug: Sterile air filled vial |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality at 90 days after randomisation
Measured: 90 days after randomisation
Secondary outcomes (10)
All-cause mortality at 28 days and 6 months after randomisation
Measured: 28 days and 6 months after randomisation
Time to resolution of shock
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.
Measured: MAP goal for >24 hours without vasopressors or inotropes. Up to 90 days after randomisation.
Recurrence of shock
Recurrence of shock - defined as a new episode of shock after reversal of the initial episode.
Measured: Up to90 days after randomisation
Duration of ICU stay
Measured: Up to 90 days after randomisation
Duration of hospital stay
Measured: Up to 90 days after randomisation
Frequency and duration of mechanical ventilation
Measured: Up to 90 days after randomisation
Duration of renal replacement therapy
Measured: Up to 90 days after randomisation
Development of bacteraemia
Measured: 2 and 14 days post randomisation
Bleeding requiring blood transfusions received in the ICU
Measured: Up to 90 days after randomisation
Quality of Life assessment at 6 months.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study start13 Jun 2012
- Primary completion22 Oct 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Australian and New Zealand Intensive Care Society Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Balasubramanian Venkatesh, Study chair, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448109
- Sponsor's protocol ID
- GI-CCT372273
- Acronym
- ADRENAL
- Status last verified
- Sep 2017
- First submitted
- 5 Oct 2011
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38239409Li 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.
PubMed 37853343Venkatesh 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.
PubMed 29347874
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Blinded Placebo Controlled Trial of Hydrocortisone in Critically Ill Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT01448109
- Acronym / sponsor ID
- ADRENAL / GI-CCT372273
- Conditions
- Septic Shock
- Keywords
- Sepsis, Corticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,800 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Australian and New Zealand Intensive Care Society Clinical Trials Group
- Study start
- 13 Jun 2012 (actual)
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective To evaluate the impact of intravenous hydrocortisone versus placebo on all cause mortality at 90 days in critically ill patients with septic shock. The hypothesis is that hydrocortisone, compared to placebo, reduces 90-day all-cause mortality in patients admitted to an ICU with septic shock. 'Shock' is defined as the need for vasopressors or inotropes to maintain a systolic blood pressure > 90 millimetres of mercury (mmHg), or mean arterial blood pressure > 60mmHg or a mean arterial pressure (MAP) target set by the treating clinician for maintaining perfusion. 'Septic shock' is shock that is secondary to sepsis
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Active comparator | Drug: Hydrocortisone |
| Sterile air filled vial | Placebo comparator | Drug: Sterile air filled vial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years or older
- Documented site of infection, or strong suspicion of infection, with 2 of the 4 clinical signs of inflammation:
- Being treated with mechanical ventilation at the time of randomisation
- 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
- Administration of vasopressors or inotropes for = 4 hours and present at time of randomisation.
Key exclusion criteria (9 listed)
- Met all inclusion criteria more than 24 hours ago
- Clinician expects to prescribe systemic corticosteroids for an indication other than septic shock (not including nebulised or inhaled corticosteroid)
- Patients treated with etomidate
- Patients receiving treatment with Amphotericin B for systemic fungal infections at time of randomisation
- Patients with documented cerebral malaria at the time of randomisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: Solu-CortefHydrocortisone 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 | Hydrocortisone |
| Sterile air filled vialthe "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 | Drug | Sterile air filled vial |
Primary outcome
All cause mortality at 90 days after randomisation
Time frame: 90 days after randomisation
10 secondary outcomes
All-cause mortality at 28 days and 6 months after randomisation
Time frame: 28 days and 6 months after randomisation
Time to resolution of shock
Time frame: MAP goal for >24 hours without vasopressors or inotropes. Up to 90 days after randomisation.
Recurrence of shock
Time frame: Up to90 days after randomisation
Duration of ICU stay
Time frame: Up to 90 days after randomisation
Duration of hospital stay
Time frame: Up to 90 days after randomisation
Frequency and duration of mechanical ventilation
Time frame: Up to 90 days after randomisation
Duration of renal replacement therapy
Time frame: Up to 90 days after randomisation
Development of bacteraemia
Time frame: 2 and 14 days post randomisation
Bleeding requiring blood transfusions received in the ICU
Time frame: Up to 90 days after randomisation
Quality of Life assessment at 6 months.
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Derived from this study: PubMed 38239409Daubney 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.
- Derived from this study: PubMed 37853343Li 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.
- Derived from this study: PubMed 29347874Venkatesh 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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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balasubramanian Venkatesh study chair
The George Institute
70 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone and Sterile air filled vial in people with Septic Shock, run by The George Institute at 70 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Australia, United Kingdom, New Zealand, Saudi Arabia, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality at 90 days after randomisation (time frame: 90 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448109, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.