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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• ∆RASrFC value in echocardiography after a fluid challenge [Срок оценки: Baseline]
• ∆RASrFC value in echocardiography after a fluid challenge [Срок оценки: 10 minutes]
• ∆RASrFC value in echocardiography after a fluid challenge [Срок оценки: 30 minutes]
• ∆RASrFC value in echocardiography after a fluid challenge [Срок оценки: 45 minuntes]

Вторичные конечные точки (7)

• ∆RASr value after the PLR maneuver [Срок оценки: 10 minutes]
• Comparison between SV measured by TTE and SV measured [Срок оценки: 10 minutes]
• Association between RASr and CVP [Срок оценки: 45 minutes]
• Evaluation of right ventricular-arterial coupling in the context of septic shock [Срок оценки: Baseline]
• Evaluation of right ventricular-arterial coupling in the context of septic shock [Срок оценки: 10 minutes]
• Evaluation of right ventricular-arterial coupling in the context of septic shock [Срок оценки: 30 minutes]
• Evaluation of right ventricular-arterial coupling in the context of septic shock [Срок оценки: 45 minutes]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU Amiens Picardie — Amiens

Идентификаторы

NCT: NCT06492044 · PI2022_843_0104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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