Septic ShockPhase 3NCT02266589
Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
A Phase 3 study testing Hydrocortisone in people with Septic Shock and Sepsis, run by Nanjing PLA General Hospital.
Trial summary
The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Sepsis
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Oct 2013
- Phase
- Phase 3
- 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
- All patients(age≧18y)
- Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)
Who cannot join
- Lactation
- Mental disorders
- Disseminated cancer
- Secondary cancers
- Inflammatory bowel disease, or diseases hindering epidural analgesia
About this study
Official title: Research of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.
Read the detailed description
Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.
- Conditions
- Septic Shock, Sepsis
- Being tested
- Hydrocortisone
- Keywords
- coagulopathy, hydrocortisone, organ failure, hemodynamic improvement induced by hydrocortisone
- Medical subject headings
- Shock, Septic, Sepsis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | little doses of hydrocortisone Receives: Drug: Hydrocortisone |
| Placebo | No intervention | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
coagulopathy
ISTH score
Measured: 30 days after inclusion
Secondary outcomes (2)
death
Measured: 30 days after inclusion
clinical complications
MODS SOFA score
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Tao, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266589
- Sponsor's protocol ID
- 2011NLY031
- Status last verified
- Oct 2014
- First submitted
- 12 Oct 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT02266589
- Acronym / sponsor ID
- 2011NLY031
- Conditions
- Septic Shock, Sepsis
- Keywords
- coagulopathy, hydrocortisone, organ failure, hemodynamic improvement induced by hydrocortisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Oct 2014 (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 stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.
Detailed description
Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.
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 | Experimental | Drug: Hydrocortisonelittle doses of hydrocortisone |
| Placebo | No intervention | –Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients(age≧18y)
- Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)
Key exclusion criteria (5 listed)
- Lactation
- Mental disorders
- Disseminated cancer
- Secondary cancers
- Inflammatory bowel disease, or diseases hindering epidural analgesia
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 |
|---|---|---|
| HydrocortisoneHydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs | Drug | Hydrocortisone |
Primary outcome
coagulopathy
Time frame: 30 days after inclusion
ISTH score
2 secondary outcomes
death
Time frame: 30 days after inclusion
clinical complications
Time frame: 30 days after inclusion
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 17 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone in people with Septic Shock and Sepsis, run by Nanjing PLA General Hospital.
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 2 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 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
coagulopathy (time frame: 30 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2014.