Septic ShockNARCOSENCT03258619
Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock
An observational study of Septic Shock, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response to the ACTH stimulation test, it is recommended to systematically start steroid replacement therapy with hydrocortisone hemisuccinate… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Aldosterone / renin dosage and Natriuresis
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to 15 Nov 2017
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalised for septic shock
Who may be able to join
- persons who have consented to take part
- Patients aged 18 to 85 years
- Admitted to an ICU for a first episode of septic shock
- With a dose of noradrenaline ≥ 0.25µg/kg/min
- Undergoing treatment with Hydrocortisone Hemisuccinate (HCHS)
Who cannot join
- Adult under guardianship
- Patients without national health insurance cover
- Pregnant or breast-feeding women
- Immunodepression (AIDS, corticosteroid treatment > 3 weeks, Organ graft, treatment with immunosuppressants)
- Recent intake of diuretics (< 6 h)
- Long-term ACE inhibitors or ARAII
Show all 10Show fewer
- Chronic kidney failure (clearance < 60)
- Cirrhosis Child ≥ B
- Chronic heart failure (NYHA III and IV)
- Decision to limit or to stop treatment
Trial locations and contacts
1 site in 1 country.
About this study
Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response to the ACTH stimulation test, it is recommended to systematically start steroid replacement therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not respond to fluid resuscitation and who continue to suffer from haemodynamic instability despite increasing doses of noradrenaline.
The interest of this corticosteroid therapy lies in its ability to reduce the duration of treatment with catecholamines, though the results are conflicting with regard to an eventual benefit for mortality.
Read more
Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood glucose dysregulation.
Today, there is no way to identify a population of patients who respond to corticosteroid therapy.
From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also exert mineralocorticoid effects able to compensate for the impaired renin angiotensin aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.
This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is defined by a plasma aldosterone/ plasma renin ratio < 2. It is associated with natriuresis >30 mmol/l.
We hypothesise that natriuresis > 30 mmol/l will make it possible to identify patients who respond to steroid replacement therapy in terms of catecholamine use.
- Conditions
- Septic Shock
- Being tested
- Aldosterone / renin dosage, Natriuresis
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldosterone / renin dosageBiological
Plasma levels of aldosterone and renin
NatriuresisBiological
natriuresis levels
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in doses of noradrenaline
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start27 Feb 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
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.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258619
- Sponsor's protocol ID
- Bouhemad-Nguyen 2016
- Acronym
- NARCOSE
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2017
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock
- ClinicalTrials.gov ID
- NCT03258619
- Acronym / sponsor ID
- NARCOSE / Bouhemad-Nguyen 2016
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 23 Aug 2017 (actual)
- 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.
Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response to the ACTH stimulation test, it is recommended to systematically start steroid replacement therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not respond to fluid resuscitation and who continue to suffer from haemodynamic instability despite increasing doses of noradrenaline.
The interest of this corticosteroid therapy lies in its ability to reduce the duration of treatment with catecholamines, though the results are conflicting with regard to an eventual benefit for mortality.
Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood glucose dysregulation.
Today, there is no way to identify a population of patients who respond to corticosteroid therapy.
From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also exert mineralocorticoid effects able to compensate for the impaired renin angiotensin aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.
This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is defined by a plasma aldosterone/ plasma renin ratio < 2. It is associated with natriuresis >30 mmol/l.
We hypothesise that natriuresis > 30 mmol/l will make it possible to identify patients who respond to steroid replacement therapy in terms of catecholamine use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalised for septic shock
Key inclusion criteria (5 listed)
- persons who have consented to take part
- Patients aged 18 to 85 years
- Admitted to an ICU for a first episode of septic shock
- With a dose of noradrenaline ≥ 0.25µg/kg/min
- Undergoing treatment with Hydrocortisone Hemisuccinate (HCHS)
Key exclusion criteria (10 listed)
- Adult under guardianship
- Patients without national health insurance cover
- Pregnant or breast-feeding women
- Immunodepression (AIDS, corticosteroid treatment > 3 weeks, Organ graft, treatment with immunosuppressants)
- Recent intake of diuretics (< 6 h)
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 |
|---|---|---|
| Aldosterone / renin dosagePlasma levels of aldosterone and renin | Biological | – |
| Natriuresisnatriuresis levels | Biological | – |
Primary outcome
Variation in doses of noradrenaline
Time frame: Day 3
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 28 Feb 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Centre Hospitalier Universitaire Dijon 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 5 inclusion and 10 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 28 Feb 2024. 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. 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?
Variation in doses of noradrenaline (time frame: Day 3). 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 28 Feb 2024.