Evaluating heart function and fluid response in septic shock patients
Official title: Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock
Run by Centre Hospitalier Universitaire, Amiens · NCT06492044 · Data updated 2026-11-12
This study is testing if measuring heart function can help doctors decide which septic shock patients will benefit from extra fluids to improve their treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | October 10, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | July 10, 2024 |
| Trial ID | NCT06492044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old hospitalized in the ICU with septic shock requiring fluid resuscitation.
✕Probably not a fit
Patients with poor echocardiographic image quality or contraindications to the passive leg raising maneuver may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses how changes in right atrial reservoir strain can predict fluid responsiveness in patients experiencing septic shock. It utilizes transthoracic echocardiography to measure cardiac output changes after fluid challenges. The goal is to identify patients who will benefit from additional fluid resuscitation, thereby optimizing their treatment and avoiding unnecessary fluid administration. The study focuses on adult patients in the intensive care unit who meet specific criteria related to septic shock.
Why it matters
Potential benefit: If successful, this study could lead to more effective fluid management in septic shock patients, improving their outcomes.
How similar studies have gone: Other studies have shown promise in using echocardiographic measures to assess fluid responsiveness, indicating this approach has potential based on prior findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (\>18 years old) * Patient hospitalized in the Intensive Care Unit at Amiens University Hospital with septic shock for less than 48 hours, defined by the presence of all the following criteria: presence of sepsis, hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mmHg despite adequate prior fluid resuscitation, and blood lactate levels \> 2 mmol/l (18 mg/dl). * Patient requiring fluid resuscitation with crystalloids/colloids * Patient on invasive mechanical ventilation in assisted-controlled mode. * Blood pressure monitored via a radial or femoral arterial catheter connected to a MostCareUp (Vygon, France). * Patient or family informed and non-opposition documented. Exclusion Criteria: * Poor echocardiographic image quality preventing RASr assessment * Patient with a contraindication to the PLR maneuver: severe head trauma or intracranial hypertension * Patient with a history of pericardiectomy * Patient with a clinical examination consistent with abdominal compartment syndrome * Patient with aortic pathology, mitral regurgitation greater than grade 2, tricuspid regurgitation greater than grade 2, mitral stenosis, or intracardiac shunt * Patient with internal or external atrial/ventricular pacing * Pregnant woman * Patient on extracorporeal membrane oxygenation and mechanical circulatory support * Moribund patient * Patient with supraventricular or ventricular arrhythmia during echocardiographic measurement series * Patient on renal replacement therapy during echocardiographic examination
Where it's running
-
CHU Amiens Picardie
Amiens, France Recruiting
Study contacts
- Study coordinator: Christophe Beyls, MD
- Email: beyls.christophe@chu-amiens.fr
- Phone: 03 22 08 80 51
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.