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临床试验/NCT06492044
NCT06492044招募中不适用

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

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
∆RASrFC value in echocardiography after a fluid challenge

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

∆RASrFC value in echocardiography after a fluid challenge

时间窗: 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).

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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