跳至主要内容
临床试验/NCT05881603
NCT05881603招募中不适用

Prevalence of Venous conGestion and Its Association With Renal Injuries Evaluated by the VExUS Score On Admission With UltraSound in Patients With Cardiogenic Pulmonary Edema

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Estimate the prevalence of the different grades of venous congestion assessed by the VExUS score in ultrasound

研究概览

简要总结

Acute respiratory distress (ARD) is a frequent reason for seeking care in emergency medicine and represents an important cause of morbidity and mortality. Among the various etiologies, Acute Cardiogenic Pulmonary Edema (C APE) currently represents one of the main causes of ARD, particularly in the elderly, with a prevalence of 43% and an estimated mortality of 21%. According to the recommendations issued in 2021 by the European Society of Cardiology (ESC), the treatment of cardiogenic APE is currently based on a triptych combining:

  • Oxygen therapy with an Saturation of Hemoglobin with Oxygen (SpO2) target > 94% and the use of non-invasive ventilation (NIV),
  • A vasodilator administered intravenously (IV),
  • A loop diuretic by IV route. Although most C APE are today considered to occur in a context of hypervolaemia and are uniformly treated by the administration of diuretics according to the recommendations in force, several works underline the fact that a non-negligible part of these clinical pictures would occur in patients with no water and sodium overload but with "relative" hypervolaemia masking euvolaemia or even hypovolaemia.

At present, no additional examination is recommended to determine the patient's volume status. However, it has been shown more recently that some patients who do not have absolute hypervolaemia could develop acute renal complications during treatment for C APE. In addition, systematic treatment with loop diuretics in patients without absolute hypervolaemia could be harmful by inducing post-treatment hypovolaemia.

At the present time, there are no data from the literature having been interested in the possible association existing between the state of blood volume of the patient on admission and the occurrence of renal complications in the aftermath of the treatment. initial. The prevalence of renal complications was nevertheless evaluated at 9% in this category of patients. The estimated prevalence of this complication and its particular seriousness, particularly in the case of chronic acute kidney injury, as well as its cost to society, justify carrying out a study aimed at evaluating the prevalence of venous congestion in the acute phase and of its possible association with the occurrence of renal complications in the course of this.

Among the various methods for assessing blood volume status, there is a growing literature regarding the use of clinical ultrasound in emergency medicine (ECMU). More recently, an ultrasound score called "VExUS score" (Venous Excess Ultrasound Score) has been developed. This offers the possibility of evaluating and classifying in 4 grades of increasing severity, simply and quickly, the state of venous congestion of patients. This score is based on the presence or absence of venous Doppler ultrasound abnormalities assessed at the level of the inferior vena cava, at the level of the supra-hepatic veins, of the portal and renal venous flow. This score, adapted to the practice of ECMU and making it possible to distinguish patients with or without venous congestion criteria, could provide arguments to guide diuretic treatment by offering personalized care. This evaluation would ultimately make it possible to offer diuretic treatment only in the event of signs suggestive of absolute hypervolaemia and thus avoid the occurrence of complications related to inappropriate therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 years old
  • Diagnosis of cardiogenic Acute Pulmonary Edema defined by the association of clinical acute respiratory distress (current breath rate > 25/min, indrawing, flapping of the wings of the nose, thoraco-abdominal rocking, signs of hypoxemia, signs of hypercapnia) AND signs of pulmonary overload (clinical, biological and radiological arguments).
  • Having given their non-objection to participation in the study (or non-objection of a loved one in an emergency context)

排除标准

  • Breastfeeding in progress
  • Known hypersensitivity to furosemide
  • History of kidney transplantation
  • Known water and electrolyte disorder
  • Hepatic encephalopathy
  • Suspicion of obstruction in the urinary tract
  • Person deprived of liberty by judicial or administrative decision, minor, person subject to a measure of legal protection

结局指标

主要结局

Estimate the prevalence of the different grades of venous congestion assessed by the VExUS score in ultrasound

时间窗: within 12 hours of admission

VExUS score in ultrasound score 0 to 3 / Higher score means worse outcome

次要结局

  • Assess the association between the grade of the VExUS ultrasound score on admission and the total and daily dose of furosemide administered to the patient(7 days)
  • Evaluate the association between the different ultrasound grades of venous congestion described by the ultrasound VExUS score and the occurrence of renal complications during hospitalization defined by the MAKE-Discharge(7 days, 30 days, 180 days)
  • Evaluate the association between the presence of venous congestion (VExUS score ≥ 1) or not and vital and functional status : Activities of daily living(day 7, day 30, day 180)
  • Evaluate the kinetics of evolution of the VExUS ultrasound score performed at the patient's bedside in comparison with the values found on admission(within 12 hours of admission , day 3 day 7)
  • Evaluate the association between the presence of venous congestion (VExUS score ≥ 1) or not and vital and functional status : Gerontological autonomy iso-resource groups(day 7, day 30, day 180)
  • Evaluate the association between the presence of venous congestion (VExUS score ≥ 1) or not and vital and functional status : Barthel Index(day 7, day 30, day 180)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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