Septic ShockNCT02580240
Initiation of Hydrocortisone for the Treatment of Septic Shock
A study testing Hydrocortisone and saline in people with Septic Shock, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients. 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 saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- age 18 years old or older;
- onset of septic shock within 6 h
Who cannot join
- Systemic corticosteroid therapy within the last 3 months before septic shock;
- high-dose steroid therapy;
- immunosuppression;
- refusal of the attending staff or patient family.
Trial locations and contacts
1 site in 1 country.
China1 site
Northern Jiangsu Province people's hospital
Yangzhou, Jiangsu, 225000
About this study
Official title: Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.
- Conditions
- Septic Shock
- Being tested
- Hydrocortisone, saline
- Keywords
- septic shock, hydrocortisone, mortality
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called cortisol
Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
salineDrug
Also called Normal saline
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. Receives: Drug: saline |
| hydrocortisone | Experimental | Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Mortality
Death from any cause at 28 days after the onset of septic shock
Measured: 28 days
Secondary outcomes (1)
All Cause Mortality
Death from any cause at 90 days after the onset of septic shock
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-quan Lv, Northern Jiangsu People's Hospital
- Investigators
- Qingquan Lv, Master, Principal investigator, Department of Critical Care Medicine, Northern Jiangsu Province people's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580240
- Sponsor's protocol ID
- 2015KY-127
- Status last verified
- Apr 2017
- First submitted
- 18 Oct 2015
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lv QQ, Gu XH, Chen QH, Yu JQ, Zheng RQ. Early initiation of low-dose hydrocortisone treatment for septic shock in adults: A randomized clinical trial. Am J Emerg Med. 2017 Dec;35(12):1810-1814. doi: 10.1016/j.ajem.2017.06.004. Epub 2017 Jun 5.
PubMed 28615145
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02580240
- Acronym / sponsor ID
- 2015KY-127
- Conditions
- Septic Shock
- Keywords
- septic shock, hydrocortisone, mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Posted 7 Aug 2017
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 : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.
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: salineVials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. |
| hydrocortisone | Experimental | Drug: HydrocortisoneHydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 years old or older;
- onset of septic shock within 6 h
Key exclusion criteria (4 listed)
- Systemic corticosteroid therapy within the last 3 months before septic shock;
- high-dose steroid therapy;
- immunosuppression;
- refusal of the attending staff or patient family.
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: cortisolHydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). | Drug | hydrocortisone |
| salineAlso: Normal salineVials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. | Drug | Placebo |
Primary outcome
28-day Mortality
Time frame: 28 days
Death from any cause at 28 days after the onset of septic shock
1 secondary outcome
All Cause Mortality
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28615145Lv QQ, Gu XH, Chen QH, Yu JQ, Zheng RQ. Early initiation of low-dose hydrocortisone treatment for septic shock in adults: A randomized clinical trial. Am J Emerg Med. 2017 Dec;35(12):1810-1814. doi: 10.1016/j.ajem.2017.06.004. Epub 2017 Jun 5.
- Individual participant dataSharing planned: No
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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.
Qingquan Lv, Master principal investigator
Department of Critical Care Medicine, Northern Jiangsu Province people's hospital
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 and saline in people with Septic Shock, run by Northern Jiangsu People's Hospital at 1 site in China.
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 4 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 7 Aug 2017. 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 China. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
28-day 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 NCT02580240, 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 7 Aug 2017.