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

Not Applicable

Recruiting

• Conditions: Right Ventricle; Fluid Responsivness
• Interventions: Other: Transthoracic echocardiography (TTE)

• Registration Number: NCT06492044
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-10
• Status Verified: 2024-06
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
o Patient with septic shock for less than 48 hours	Transthoracic echocardiography (TTE)	-

Primary Outcome Measures

Name	Time	Method
∆RASrFC value in echocardiography after a fluid challenge	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 Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France