Using echocardiography to improve fluid management in septic shock patients

Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management: a Multicentric, Randomized, Controlled, Open Label Pilot-study

This study is testing if using ultrasound to guide fluid treatment can help critically ill patients with septic shock feel better and avoid complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 1 site (Nîmes)
• Trial ID: NCT06043505 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of an echocardiographic algorithm in optimizing hemodynamic management during the first four days of treatment for patients with septic shock. By utilizing transthoracic echocardiography and lung ultrasound, the study aims to enhance fluid resuscitation strategies and reduce the risks associated with fluid overload and hypovolemia. The trial is multicenter and randomized, focusing on critically ill patients in intensive care units who meet specific inclusion criteria. The goal is to determine whether this echographic approach can lead to better patient outcomes in septic shock management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who develop septic shock while in an intensive care unit.

Not a fit: Patients with conditions such as cardiac tamponade, infective endocarditis, or severe dilated cardiomyopathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve fluid management and reduce mortality rates in patients experiencing septic shock.

How similar studies have performed: While the use of echocardiography in hemodynamic assessment is established, this specific approach to optimizing fluid management in septic shock is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Nîmes

• CHU de Nimes — Nîmes, France (Recruiting)

Study contacts

• Principal investigator: Claire Roger — CHU Nimes
• Study coordinator: Claire Roger, MD

Conditions Shock, Septic; Hemodynamic Instability; Monitoring; Transthoracic Echocardiography; Blood Volume; Fluid management