Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock (RAS-FR)

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.

Study Overview

• Status: Recruiting
• Conditions: Right Ventricle; Fluid Responsivness
• Intervention / Treatment: Other: Transthoracic echocardiography (TTE)

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Beyls, MD; Phone Number: 03 22 08 80 51; Email: beyls.christophe@chu-amiens.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
    • Contact: Christophe Beyls, MD; Phone Number: 0322087866; Email: Beyls.Christophe@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: o Patient with septic shock for less than 48 hours

Other: Transthoracic echocardiography (TTE); In this pilot study, all included patients will undergo a TTE before (TTEt0) and after (TTEt1) the PLR maneuver, then before (TTEt2) and after the FC (TTEt3). Passive leg raising is PLR. FC is fluid challenge. TTE, PLR and FC are routine care procedures in patient in septic shock. In this study the patient will undergo repeated image acquisition with TTE at different times as part of the study, resulting in a longer TTE procedure. The advantage of TTE is that it is a non-invasive, painless, non-irradiating procedure that can be easily performed at the patient's bedside and has no known side effects to date. TTE is a non-invasive procedure that poses no infectious or psychological risk to the patient. No additional follow-up or telephone contact will be necessary for the study. The study concludes once TTEt3 is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
∆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

Outcome Measure	Measure Description	Time Frame
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
∆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.	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: preload; right ventricle; Right atrial strain; fluid responsivness
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Wounds and Injuries; Shock; Sepsis; Shock, Septic; Sprains and Strains
• Other Study ID Numbers: PI2022_843_0104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No