Evaluating heart function and fluid response in septic shock patients

Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock

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

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire, Amiens (other)
• Locations: 1 site (Amiens)
• Trial ID: NCT06492044 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old hospitalized in the ICU with septic shock requiring fluid resuscitation.

Not a fit: Patients with poor echocardiographic image quality or contraindications to the passive leg raising maneuver may not benefit from this study.

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 performed: Other studies have shown promise in using echocardiographic measures to assess fluid responsiveness, indicating this approach has potential based on prior findings.

Eligibility 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 this trial is running

Amiens

• CHU Amiens Picardie — Amiens, France (RECRUITING)

Study contacts

• Study coordinator: Christophe Beyls, MD

Conditions: Fluid Responsivness, Right Ventricle, Right atrial strain, fluid responsivness, preload, right ventricle