Septic ShockPhase 4HSHC00582434NCT02768740
Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock.
A Phase 4 study testing Hydrocortisone hemisuccinate in people with Septic Shock, run by Association Niçoise de Réanimation Médicale.
Trial summary
We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg… 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 hemisuccinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Sep 2014
- 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
- patients over 18 years old
- septic shock in accordance with the American College of Chest Physicians/Society of Critical Care Medicine Consensus Committee criteria. Septic shock was managed in accordance with the 2004 edition of the Surviving Sepsis Campaign guidelines.
- no minimal vasopressor dose was needed to enter the trial.
Who cannot join
- medical history of adrenal insufficiency
- ongoing corticosteroid treatment
- pregnancy
About this study
Official title: Double Blinded, Randomized Trial, Comparing Intravenous Bolus of 50 mg of Hydrocortisone Every 6 Hours for 7 Days With a Continuous Infusion of 300 mg Per Day of Hydrocortisone 300-mg Group During 5 Days in the Treatment of Septic Shock.
We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of treatment.
Read the detailed description
Hydrocortisone hemisuccinate (Hydrocortisone Upjohn) was supplied as a powder in 100 mg vials to be reconstituted with 2 ml of sterile water diluent. The placebo was saline serum supplied as 10 ml ampoules. The study drugs were administered according to two protocols. In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. In the two groups, hydrocortisone was stopped abruptly at the end of treatment. The investigators had the choice or resuming hydrocortisone at the end of the fifth day if deemed necessary.
- Conditions
- Septic Shock
- Being tested
- 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.
Hydrocortisone hemisuccinateDrug
Also called Saline solution as placebo
In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days.
| Study group | Role | What they receive |
|---|---|---|
| 200 mg group | Active comparator | Patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. Receives: Drug: Hydrocortisone hemisuccinate |
| 300 mg group | Experimental | Patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. Receives: Drug: Hydrocortisone hemisuccinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The primary end point was to determine a difference in 28-day mortality between the 200-mg and 300-mg groups.
Measured: 28-day
Secondary outcomes (4)
Incidence of permanent shock between groups
Permanent shock (PS) was defined as permanent catecholamine support (epinephrine or norepinephrine) in the ICU, from the onset of septic shock to death without a period of reversal.
Measured: 28-day
Incidence of shock relapse between groups
Shock relapse (SR) was defined as recurrence of septic shock requiring catecholamine resumption.
Measured: 28-day
Incidence of post hydrocortisone hemodynamic rebound between groups
Post hydrocortisone hemodynamic rebound (PHHR) was defined as SR within 48 hours after hydrocortisone cessation.
Measured: 28-day
Incidence of adverse events between groups.
Incidences of hemorrhagic events, superinfections and the amount of needed insulin were compared between the two groups.
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startApr 2008
- Primary completionMay 2010
- Study completionSep 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Niçoise de Réanimation Médicale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Bernardin, M.D., Principal investigator, Association Niçoise de Réanimation Médicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768740
- Sponsor's protocol ID
- 2007-005824-34
- Acronym
- HSHC00582434
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The data are available for additional analysis
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized Trial, Comparing Intravenous Bolus of 50 mg of Hydrocortisone Every 6 Hours for 7 Days With a Continuous Infusion of 300 mg Per Day of Hydrocortisone 300-mg Group During 5 Days in the Treatment of Septic Shock.
- ClinicalTrials.gov ID
- NCT02768740
- Acronym / sponsor ID
- HSHC00582434 / 2007-005824-34
- Conditions
- Septic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Association Niçoise de Réanimation MédicaleUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 May 2016 (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.
We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of treatment.
Detailed description
Hydrocortisone hemisuccinate (Hydrocortisone Upjohn) was supplied as a powder in 100 mg vials to be reconstituted with 2 ml of sterile water diluent. The placebo was saline serum supplied as 10 ml ampoules. The study drugs were administered according to two protocols. In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. In the two groups, hydrocortisone was stopped abruptly at the end of treatment. The investigators had the choice or resuming hydrocortisone at the end of the fifth day if deemed necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 mg group | Active comparator | Drug: Hydrocortisone hemisuccinatePatients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. |
| 300 mg group | Experimental | Drug: Hydrocortisone hemisuccinatePatients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years old
- septic shock in accordance with the American College of Chest Physicians/Society of Critical Care Medicine Consensus Committee criteria. Septic shock was managed in accordance with the 2004 edition of the Surviving Sepsis Campaign guidelines.
- no minimal vasopressor dose was needed to enter the trial.
Key exclusion criteria (3 listed)
- medical history of adrenal insufficiency
- ongoing corticosteroid treatment
- pregnancy
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 |
|---|---|---|
| Hydrocortisone hemisuccinateAlso: Saline solution as placeboIn the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. | Drug | 200 mg group, 300 mg group |
Primary outcome
Mortality
Time frame: 28-day
The primary end point was to determine a difference in 28-day mortality between the 200-mg and 300-mg groups.
4 secondary outcomes
Incidence of permanent shock between groups
Time frame: 28-day
Incidence of shock relapse between groups
Time frame: 28-day
Incidence of post hydrocortisone hemodynamic rebound between groups
Time frame: 28-day
Incidence of adverse events between groups.
Time frame: 28-day
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 23 May 2016.
- Individual participant dataSharing planned: Undecided. The data are available for additional analysis
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
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.
Gilles Bernardin, M.D. principal investigator
Association Niçoise de Réanimation Médicale
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone hemisuccinate in people with Septic Shock, run by Association Niçoise de Réanimation Médicale.
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 3 inclusion and 3 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 23 May 2016. 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 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?
Mortality (time frame: 28-day). 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 23 May 2016.