Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shoc… (NCT06043505) | Clinical Trial Compass
CompletedNot Applicable
Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management
France136 participantsStarted 2024-02-08
Plain-language summary
Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.
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.
All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below.
Inclusion Criteria
* Patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by SEPSIS-3 criteria.
* Patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation.
* Patient affiliated or beneficiary of a health insurance plan.
* Patient at least (≥) 18 years of age.
Exclusion Criteria:
* Refusal of consent.
* Patient under court protection or guardianship.
* Moribund patient with a life expectancy of less than 48 hours.
* Non-echogenic patient.
* Cardiac tamponade.
* Infective endocarditis.
* Intracavitary thrombus.
* Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction\<40%.
* Parturient or nursing patient.
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.
1This trial used ultrasound-guided monitoring to manage fluid levels during the first 4 days of septic shock — is that kind of echocardiographic approach something my care team already uses, or is it considered experimental in this setting?
2Since this study specifically tracked how much IV fluid was given over the first 4 days, what does my doctor think is the right fluid management strategy for my situation, and how would they decide when to give more or less fluid?
3This trial is now completed — has my doctor seen or would they be able to review any results from it, and do those findings change how they might approach my hemodynamic management?
4Because this was a Phase NA study focused on a monitoring algorithm rather than a drug, does that mean the main unknowns are about whether this ultrasound-guided approach leads to better outcomes compared to standard monitoring, and where does that evidence currently stand?
5Given that septic shock can change rapidly, how would my doctor decide between following a structured algorithm like the one tested in this trial versus making more individualized moment-to-moment decisions about my fluid and hemodynamic care?
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
Volume of vascular filling during the first 4 days