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NCT Number: NCT07721974

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
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.

Exclusion criteria

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).

Treatment and study plan

Collection of fluid samples

Other

blood sample and urinary

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien PICOD, PhD

CONTACT

[email protected]

+33 1 48 95 55 55

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

" Étude Des altérations du système rénine-angiotensine-aldostérone au Cours du Choc Septique " Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock

Acronym: ARES

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: Jul 23, 2026
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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