Septic ShockARESNCT07721974
Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock
A study testing Collection of fluid samples in people with Septic Shock, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Septic shock is a common and life-threatening condition associated with an in-hospital mortality rate exceeding 40%. The symptomatic management of septic shock relies primarily on vasopressor therapy, particularly norepinephrine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Shock
- What is being tested?
- Collection of fluid samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with septic shock:
- Proven or suspected infection.
- Persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation.
- Hyperlactatemia > 2 mmol/L.
- Adult critically ill control patients with sepsis without circulatory failure:
- Proven or suspected infection.
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- Absence of persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg.
- An increase of at least 2 points in the SOFA score attributable to infection.
- Adult critically ill control patients with cardiogenic shock:
- Acute cardiac disease, such as myocardial infarction.
- Persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation.
- Low cardiac output: cardiac index < 2.2 L/min/m² or the need for inotropic support (including norepinephrine) to maintain a cardiac index > 2.2 L/min/m².
- Elevated left ventricular filling pressures, measured invasively or estimated by echocardiography.
- Hyperlactatemia > 2 mmol/L.
- Adult healthy volunteers:
- Absence of active or chronic disease.
- Absence of long-term medication use.
- No surgery or medication intake within the previous month.
- Absence of ongoing pregnancy.
- Non-smoker.
Who cannot join
- Patients deprived of liberty by judicial or administrative decision.
- Patients admitted to the intensive care unit for more than 48 hours.
- Patients previously enrolled in an interventional study with overlapping follow-up.
- Patients benefiting from State Medical Aid (AME).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: " Étude Des altérations du système rénine-angiotensine-aldostérone au Cours du Choc Septique " Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock
Septic shock is a common and life-threatening condition associated with an in-hospital mortality rate exceeding 40%. The symptomatic management of septic shock relies primarily on vasopressor therapy, particularly norepinephrine. However, the use of high doses of norepinephrine may lead to adverse effects, prompting the search for alternative therapeutic strategies, including angiotensin II, which has recently been investigated as an adjunctive vasopressor.
Indeed, alterations of the renin-angiotensin-aldosterone system (RAAS), particularly a relative deficiency of angiotensin II, have been hypothesized to occur during septic shock. However, to date, no human study has used gold-standard techniques for measuring RAAS peptides to confirm this hypothesis.
Furthermore, it remains unclear whether these alterations are specific to septic shock or may also be observed in less severe infections (sepsis) or in other forms of circulatory failure, such as cardiogenic shock.
- Conditions
- Septic Shock
- Being tested
- Collection of fluid samples
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of fluid samplesOther
blood sample and urinary
| Study group | Role | What they receive |
|---|---|---|
| Patients with septic shock | Active comparator | Blood samples will be collected at 6, 24, and 72 hours after study inclusion Receives: Other: Collection of fluid samples |
| critically ill control patients | Active comparator | Critically ill control patients, including patients with sepsis without circulatory failure and patients with cardiogenic shock, will undergo blood sampling at 6, 24, and 72 hours. Receives: Other: Collection of fluid samples |
| healthy volunteer | Active comparator | blood sampling at inclusion Receives: Other: Collection of fluid samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of relative angiotensin II deficiency during septic shock
The incidence of relative angiotensin II deficiency at the different study time points (6, 24, and 72 hours), defined as a circulating angiotensin II concentration below or equal to the 95th percentile of healthy subjects in the presence of arterial hypotension (mean arterial pressure < 65 mmHg) or the need for vasopressor support to maintain a mean arterial pressure > 65 mmHg. This definition is similar to that used in previous studies to define relative vasopressin deficiency during septic shock.
Measured: From enrollment to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionOct 2031 (estimated)
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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721974
- Sponsor's protocol ID
- APHP260376
- Acronym
- ARES
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Étude Des altérations du système rénine-angiotensine-aldostérone au Cours du Choc Septique " Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock
- ClinicalTrials.gov ID
- NCT07721974
- Acronym / sponsor ID
- ARES / APHP260376
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 23 Jul 2026 (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 a common and life-threatening condition associated with an in-hospital mortality rate exceeding 40%. The symptomatic management of septic shock relies primarily on vasopressor therapy, particularly norepinephrine. However, the use of high doses of norepinephrine may lead to adverse effects, prompting the search for alternative therapeutic strategies, including angiotensin II, which has recently been investigated as an adjunctive vasopressor.
Indeed, alterations of the renin-angiotensin-aldosterone system (RAAS), particularly a relative deficiency of angiotensin II, have been hypothesized to occur during septic shock. However, to date, no human study has used gold-standard techniques for measuring RAAS peptides to confirm this hypothesis.
Furthermore, it remains unclear whether these alterations are specific to septic shock or may also be observed in less severe infections (sepsis) or in other forms of circulatory failure, such as cardiogenic shock.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with septic shock | Active comparator | Other: Collection of fluid samplesBlood samples will be collected at 6, 24, and 72 hours after study inclusion |
| critically ill control patients | Active comparator | Other: Collection of fluid samplesCritically ill control patients, including patients with sepsis without circulatory failure and patients with cardiogenic shock, will undergo blood sampling at 6, 24, and 72 hours. |
| healthy volunteer | Active comparator | Other: Collection of fluid samplesblood sampling at inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Proven or suspected infection.
- Persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation.
- Hyperlactatemia > 2 mmol/L.
- Proven or suspected infection.
- Absence of persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg.
Key exclusion criteria (4 listed)
- Patients deprived of liberty by judicial or administrative decision.
- Patients admitted to the intensive care unit for more than 48 hours.
- Patients previously enrolled in an interventional study with overlapping follow-up.
- Patients benefiting from State Medical Aid (AME).
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 |
|---|---|---|
| Collection of fluid samplesblood sample and urinary | Other | Patients with septic shock, critically ill control patients, healthy volunteer |
Primary outcome
To determine the incidence of relative angiotensin II deficiency during septic shock
Time frame: From enrollment to 72 hours
The incidence of relative angiotensin II deficiency at the different study time points (6, 24, and 72 hours), defined as a circulating angiotensin II concentration below or equal to the 95th percentile of healthy subjects in the presence of arterial hypotension (mean arterial pressure < 65 mmHg) or the need for vasopressor support to maintain a mean arterial pressure > 65 mmHg. This definition is similar to that used in previous studies to define relative vasopressin deficiency during septic shock.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of fluid samples in people with Septic Shock, run by Assistance Publique - Hôpitaux de Paris.
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 20 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: opening soon, as of the sponsor's last update on 23 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrien PICOD, PhD (+33 1 48 95 55 55, adrien.picod@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of relative angiotensin II deficiency during septic shock (time frame: From enrollment to 72 hours). 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 Jul 2026.