Skip to main content
Clinical Trials/NCT06492044
NCT06492044
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country250 target enrollmentOctober 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fluid Responsivness
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
250
Locations
1
Primary Endpoint
∆RASrFC value in echocardiography after a fluid challenge
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Evaluating preload dependence is crucial for managing fluid administration in septic shock patients. To avoid unnecessary fluid administration, it's recommended to use dynamic tests like the passive leg raising (PLR) maneuver or a fluid challenge (FC) to see if a patient's cardiac output will increase after fluid resuscitation. Transthoracic echocardiography (TTE) is preferred for this because it can non-invasively, reliably, and reproducibly measure the increase in cardiac output. A patient is considered a "responder" if their stroke volume (SV) increases by more than 15% after an FC. Two-dimensional (2D) right atrial strain (RAS) is a promising tool for evaluating right atrial function. According to the Frank-Starling law, measuring changes in the RA reservoir strain phase (RASr) can identify acute changes in preload, like those induced by a PLR maneuver or an FC.

The aims of this study are to assess the ability of ∆RASr to identify responders after a fluid challenge (FC) and to evaluate the ability of ∆RASr variation induced by a PLR maneuver to distinguish responders from non-responders to volume expansion.

Registry
clinicaltrials.gov
Start Date
October 10, 2022
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

∆RASrFC value in echocardiography after a fluid challenge

Time Frame: 45 minuntes

The ∆RASrFC will be defined as the difference between the RASr measured before the FC (RASrt2) and after the FC (RASrt3). To measure the RASr at different times, an acquisition of an apical four-chamber loop image focused on the right atrium will be performed at t0, t1, t2, and t3. The measurement of ∆RASrFC will be done offline, blinded to the results of ∆SVFC, by a cardiac echography expert using dedicated software. T3 period refers to the time after the end of the FC (15 minutes).

Secondary Outcomes

  • ∆RASr value after the PLR maneuver(10 minutes)
  • Evaluation of right ventricular-arterial coupling in the context of septic shock(45 minutes)
  • Comparison between SV measured by TTE and SV measured(10 minutes)
  • Association between RASr and CVP(45 minutes)

Study Sites (1)

Loading locations...

Similar Trials