Septic ShockNCT01284452
Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
A study testing Hydrocortisone in people with Septic Shock and Severe Sepsis, run by Mahidol University at 1 site in Thailand.
Trial summary
Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Severe Sepsis, Acute Lung Injury
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2010to Mar 2015
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Diagnosis of severe sepsis or septic shock according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference 1992
- Diagnosis of acute lung injury or acute respiratory distress syndrome according to the American-European Consensus Conference on ARDS 1994
- Onset of organ dysfunction within 12 hours before enrollment
Who cannot join
- Indicated for receive corticosteroid
- Congestive heart failure
- Contra-indication for hydrocortisone: For example: allergy to hydrocortisone
- Pregnancy
- Not agree to sign the consent form
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: Efficacy of Moderate Dose Hydrocortisone in Treatment of Severe Sepsis and Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome: A Randomized Controlled Trial
Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.
Read the detailed description
Severe sepsis/septic shock is a serious condition associated with high mortality rate. The pathophysiology of the disease involves the complex interaction between host's immunity and the microorganisms toxin. The release of immune complex and cascade of inflammatory cytokines are responsible for multiorgan dysfunction, especially the cardiovascular system. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. Both anti-inflammation and supplementation of relatively adrenal insufficiency are the main hypothesis of the benefit of hydrocortisone. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Although there is controversy about timing and favorable patients'characteristic, the information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.
- Being tested
- Placebo, Hydrocortisone
- Keywords
- Septic shock, Severe sepsis, Acute lung injury, Acute respiratory distress syndrome, ARDS
- Medical subject headings
- Shock, Septic, Sepsis, Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Normal saline 50 ml intravenous every 6 hours for 7 days
HydrocortisoneDrug
Hydrocortisone 50 mg intravenous every 6 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline 50 ml intravenous every 6 hours for 7 days Receives: Drug: Placebo |
| Hydrocortisone | Active comparator | Hydrocortisone 50 mg intravenous every 6 hours for 7 days Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Death from any cause at 28 days after diagnosis of severe sepsis/septic shock
Measured: 28 days
Secondary outcomes (4)
Ventilator free day
Day of alive within 28 days without mechanical ventilator support.
Measured: 28 day
Vasopressor free day
Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine.
Measured: 28 days
Rate of renal replacement therapy
Proportion of the patients who received renal replacement therapy within 28 days after diagnosis of severe sepsis or septic shock.
Measured: 28 days
Organ support free days
Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surat Tongyoo, Mahidol University
- Investigators
- Surat Tongyoo, MD, Principal investigator, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284452
- Sponsor's protocol ID
- Si630/2010
- Status last verified
- Apr 2015
- First submitted
- 18 Jan 2011
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tongyoo S, Permpikul C, Mongkolpun W, Vattanavanit V, Udompanturak S, Kocak M, Meduri GU. Hydrocortisone treatment in early sepsis-associated acute respiratory distress syndrome: results of a randomized controlled trial. Crit Care. 2016 Oct 15;20(1):329. doi: 10.1186/s13054-016-1511-2.
PubMed 27741949
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Moderate Dose Hydrocortisone in Treatment of Severe Sepsis and Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01284452
- Acronym / sponsor ID
- Si630/2010
- Keywords
- Septic shock, Severe sepsis, Acute lung injury, Acute respiratory distress syndrome, ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jan 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.
Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.
Detailed description
Severe sepsis/septic shock is a serious condition associated with high mortality rate. The pathophysiology of the disease involves the complex interaction between host's immunity and the microorganisms toxin. The release of immune complex and cascade of inflammatory cytokines are responsible for multiorgan dysfunction, especially the cardiovascular system. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. Both anti-inflammation and supplementation of relatively adrenal insufficiency are the main hypothesis of the benefit of hydrocortisone. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Although there is controversy about timing and favorable patients'characteristic, the information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNormal saline 50 ml intravenous every 6 hours for 7 days |
| Hydrocortisone | Active comparator | Drug: HydrocortisoneHydrocortisone 50 mg intravenous every 6 hours for 7 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and older
- Diagnosis of severe sepsis or septic shock according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference 1992
- Diagnosis of acute lung injury or acute respiratory distress syndrome according to the American-European Consensus Conference on ARDS 1994
- Onset of organ dysfunction within 12 hours before enrollment
Key exclusion criteria (5 listed)
- Indicated for receive corticosteroid
- Congestive heart failure
- Contra-indication for hydrocortisone: For example: allergy to hydrocortisone
- Pregnancy
- Not agree to sign the consent form
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 |
|---|---|---|
| PlaceboNormal saline 50 ml intravenous every 6 hours for 7 days | Drug | Placebo |
| HydrocortisoneHydrocortisone 50 mg intravenous every 6 hours for 7 days | Drug | Hydrocortisone |
Primary outcome
All cause mortality
Time frame: 28 days
Death from any cause at 28 days after diagnosis of severe sepsis/septic shock
4 secondary outcomes
Ventilator free day
Time frame: 28 day
Vasopressor free day
Time frame: 28 days
Rate of renal replacement therapy
Time frame: 28 days
Organ support free days
Time frame: 28 days
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 20 Apr 2015.
- Derived from this study: PubMed 27741949Tongyoo S, Permpikul C, Mongkolpun W, Vattanavanit V, Udompanturak S, Kocak M, Meduri GU. Hydrocortisone treatment in early sepsis-associated acute respiratory distress syndrome: results of a randomized controlled trial. Crit Care. 2016 Oct 15;20(1):329. doi: 10.1186/s13054-016-1511-2.
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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.
Surat Tongyoo, MD principal investigator
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone in people with Septic Shock and Severe Sepsis, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 5 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 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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.
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 (time frame: 28 days). 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 NCT01284452, which also lists 1 linked publication.
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 20 Apr 2015.