Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock (NCT07721974) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock
320 participantsStarted 2026-09-15
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Pati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the incidence of relative angiotensin II deficiency during septic shock