Septic ShockPhase 2/3HyStOONNCT01817153
Effect of Hydrocortison on Post-ischemic Flow-mediated Dilation and on Thenar Oxygen Saturation in Human Septic Shock.
A Phase 2/3 study testing hydrocortison hemisuccinate in people with Septic Shock and Adult, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Adult
- What is being tested?
- hydrocortison hemisuccinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2013to 5 Nov 2019
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 yrs
- consent obtained
- septic shock (according to international definition)
- patient sedated and submitted to invasive mechanical ventilation
- no need for surgery expected within 24 hours after enrollment
- patient has received at least one dose of large spectrum antibiotics
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- superior vena cava catheter in place
- patient carrying a thermodilution device for cardiac output measurement
- stable mean arterial pressure within 65-5 mmHg limits for at least 2 hours;
Who cannot join
- pregnancy
- age below 18 years
- patient treated with iv continuous epinephrine
- chronic occlusive arteriopathy of the upper limbs
- regular or recent treatment with glibenclamide or glipizide
- regular or recent treatment with steroids
- known surrenal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study.
The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).
Read the detailed description
Two primary end points, considered as reflecting vasoreactivity will be assessed :
- Flow-mediated dilation (FMD) of the brachial artery, measured by ultrasound imaging, expressed in mm or in percentage, will be calculated from artery diameters measured before and after a vascular occlusion test (cuff around arm or forearm).
- recovery slope of thenar oxygen saturation (StO2), assessed by near infrared spectroscopy (NIRS), expressed in %/second, will be recorded after the vascular occlusion test.
The two primary end points (FMD and recovery slope of StO2)will be assessed at the following timepoints :
- baseline (before first injection of placebo or hydrocortison)
- 2 hours after first injection of placebo or hydrocortison
- 2 hours after second injection of placebo or hydrocortison (i.e. 8 hours after first injection)
- 4 to 6 hours after third injection
- 4 to 6 hours after fourth injection (optional)
- Conditions
- Septic Shock, Adult
- Being tested
- hydrocortison hemisuccinate, placebo followed by hydrocortisone hemisuccinate
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortison hemisuccinateDrug
placebo followed by hydrocortisone hemisuccinateDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 10 mL normal saline iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H8, H14 and H20 Receives: Drug: placebo followed by hydrocortisone hemisuccinate |
| hydrocortison | Active comparator | 50 mg hydrocortison iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H12, H18 and H24 Receives: Drug: hydrocortison hemisuccinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasoreactivity
Measured: every 6 hours over the first 24 hours of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study start5 Nov 2013
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Why it stopped: not enough recruitment
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thierry BOULAIN, Centre Hospitalier Régional d'Orléans
- Investigators
- Thierry Boulain, MD, Principal investigator, Centre Hospitalier Régional d'Orléans, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817153
- Sponsor's protocol ID
- CHRO-2012-04
- Other IDs
- 2012-004736-39
- Acronym
- HyStOON
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2013
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study.
- ClinicalTrials.gov ID
- NCT01817153
- Acronym / sponsor ID
- HyStOON / CHRO-2012-04
- Conditions
- Septic Shock, Adult
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 22 Mar 2013 (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 main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).
Detailed description
Two primary end points, considered as reflecting vasoreactivity will be assessed :
- Flow-mediated dilation (FMD) of the brachial artery, measured by ultrasound imaging, expressed in mm or in percentage, will be calculated from artery diameters measured before and after a vascular occlusion test (cuff around arm or forearm).
- recovery slope of thenar oxygen saturation (StO2), assessed by near infrared spectroscopy (NIRS), expressed in %/second, will be recorded after the vascular occlusion test.
The two primary end points (FMD and recovery slope of StO2)will be assessed at the following timepoints :
- baseline (before first injection of placebo or hydrocortison)
- 2 hours after first injection of placebo or hydrocortison
- 2 hours after second injection of placebo or hydrocortison (i.e. 8 hours after first injection)
- 4 to 6 hours after third injection
- 4 to 6 hours after fourth injection (optional)
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: placebo followed by hydrocortisone hemisuccinate10 mL normal saline iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H8, H14 and H20 |
| hydrocortison | Active comparator | Drug: hydrocortison hemisuccinate50 mg hydrocortison iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H12, H18 and H24 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age over 18 yrs
- consent obtained
- septic shock (according to international definition)
- patient sedated and submitted to invasive mechanical ventilation
- no need for surgery expected within 24 hours after enrollment
Key exclusion criteria (7 listed)
- pregnancy
- age below 18 years
- patient treated with iv continuous epinephrine
- chronic occlusive arteriopathy of the upper limbs
- regular or recent treatment with glibenclamide or glipizide
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 |
|---|---|---|
| hydrocortison hemisuccinate | Drug | hydrocortison |
| placebo followed by hydrocortisone hemisuccinate | Drug | placebo |
Primary outcome
Vasoreactivity
Time frame: every 6 hours over the first 24 hours of intervention
Results and safety
The study was stopped early (reason given: not enough recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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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.
Thierry Boulain, MD principal investigator
Centre Hospitalier Régional d'Orléans, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hydrocortison hemisuccinate in people with Septic Shock and Adult, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 7 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: stopped early, as of the sponsor's last update on 11 Feb 2020. 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: not enough recruitment). Results are not available in the source record.
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?
Vasoreactivity (time frame: every 6 hours over the first 24 hours of intervention). 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 11 Feb 2020.