Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock
NCT Number: NCT06492044
Acronym: RAS-FR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fluid Responsivness|Right Ventricle
Interventions: OTHER: Transthoracic echocardiography (TTE)
Sponsor: Centre Hospitalier Universitaire, Amiens
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-10-10
Completion Date: 2026-12
Locations: CHU Amiens Picardie, Amiens, France

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.

Primary Outcome Measures: ∆RASrFC value in echocardiography after a fluid challenge, 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.

T0 : refers to the time before the PLR maneuver, Baseline|∆RASrFC value in echocardiography after a fluid challenge, 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.

T1 refers to the time during the PLR maneuver at the peak of the maximal velocity of the aortic VTI., 10 minutes|∆RASrFC value in echocardiography after a fluid challenge, 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.

T2 refers to the time before the fluid challenge (FC), 30 minutes|∆RASrFC value in echocardiography after a fluid challenge, 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)., 45 minuntes
Secondary Outcome Measures: ∆RASr value after the PLR maneuver, o ∆RASrPLR will be defined as the difference between the RASr measured before the PLR maneuver (RASrt0) and the RASr measured during the PLR maneuver at the peak of the maximal velocity of the aortic VTI (RASrt1).

T1 period refers to the time during the PLR maneuver at the peak of the maximal velocity of the aortic VTI., 10 minutes|Comparison between SV measured by TTE and SV measured, Comparison between SV measured by TTE and SV measured by MostCareUp during the PLR maneuver and the FC.

SV measured by MostCareUp is based on the PRAM (pressure recording analytical method). This is an uncalibrated monitoring method based on pulse wave analysis.

the T1 period refers to the time during the PLR maneuver at the peak of the maximal velocity of the aortic VTI., 10 minutes|Association between RASr and CVP, Evaluation of the association between RASr, ∆RASrFC, CVP and ∆CVP. ∆CVPFC will be defined as the difference between the CVP measured at time t2 and at time t3. CVP is measured at end-expiration using a jugular venous catheter and will be the average of three consecutive measurements.

T3 period refers to the time after the end of the FC, 45 minutes|Evaluation of right ventricular-arterial coupling in the context of septic shock, Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter., Baseline|Evaluation of right ventricular-arterial coupling in the context of septic shock, Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter., 10 minutes|Evaluation of right ventricular-arterial coupling in the context of septic shock, Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter., 30 minutes|Evaluation of right ventricular-arterial coupling in the context of septic shock, Right ventricular-arterial coupling is measured by TTE at times t0, t1, t2 and t3 using a four-chamber view and the TAPSE/PASP parameter., 45 minutes