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

NCT ID: NCT06492044

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2026-12-31

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.

Conditions

Fluid Responsivness; Right Ventricle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

o Patient with septic shock for less than 48 hours

Group Type: EXPERIMENTAL

Transthoracic echocardiography (TTE)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christophe Beyls, MD

Role: CONTACT

beyls.christophe@chu-amiens.fr

03 22 08 80 51

Facility Contacts

Christophe Beyls, MD

Role: primary

Beyls.Christophe@chu-amiens.fr

0322087866

Other Identifiers

PI2022_843_0104

Identifier Type: -

Identifier Source: org_study_id