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临床试验/NCT04436718
NCT04436718Unknown不适用

Does Serial Ultrasonographic Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?

Riverside University Health System Medical Center2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
2
主要终点
Worsening renal failure

研究概览

简要总结

This study evaluates daily POCUS/FCU exams on patients admitted for acute decompensated heart failure with primary end point of acute kidney injury while in hospital.

详细描述

Patients with admitted to hospital with Acute Decompensated Heart failure (ADHF) suffer a significant morbidity and premature mortality. Administration of intravenous (IV) diuretics is largely guided by clinical judgment based on physical exam, net fluid measurement, changes in daily weights and chest x-ray findings. The key objective is to promote adequate diuresis while improving symptoms, without compromising renal function. Laboratory tests demonstrating hemo-concentration, increasing BUN, and increasing creatinine have been proposed as positive prognostic indicators in patients receiving IV diuretic therapy but these methods suffer from inadequate predictive value. Observational studies have identified worsening renal failure (WRF) in patients admitted for heart failure as an important clinical entity associated with worsening clinical outcomes.

Point of care Ultrasound (POCUS) has the potential to fill an unmet need for monitoring patients recieving IV diuretic therapy. POCUS provides clinicians with immediate diagnostic information obtained and interpreted at bedside that can augment and enhance the physical examination. Numerous studies have examined POCUS assessment of pulmonary edema and measurement of the Inferior Vena Cava (IVC) to estimate hemodynamic parameters for patients with acute decompensated heart failure (ADHF). No study to date has examined POCUS effect on clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 admitted for acute decompensated heart failure exacerbation as primary admission diagnosis from Emergency department to General Medicine ward that are administered diuretic therapy expected to be admitted for two days or more.

排除标准

  • Decline consent for study
  • If admitted and research team not available for consent and initial evaluation prior within 6 hours of first diuretic administration
  • Patients in whom diuretics will not be utilized (i.e. anuric, ESRD on HD)
  • Inability to assess IVC (surgical anatomy, body habitus, Ileus, etc.)
  • Patients admitted to ICU
  • Patients currently on positive pressure ventilation (BiPAP)
  • Patients discharged from the emergency department
  • Patients discharged prior to evaluation by the POCUS team

结局指标

主要结局

Worsening renal failure

时间窗: During hospitalization typically one week

Serum Creatnine levels measured in mg/dL

次要结局

  • Length of stay(During hospitalization typically one week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Ulrich MD

Associate Medical Program Director

Riverside University Health System Medical Center

研究点 (2)

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