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临床试验/NCT02892227
NCT02892227已完成不适用

MANAGEMENT OF ACUTE HEART FAILURE: THE CONTRIBUTION OF DAILY 'BEDSIDE' ULTRASOUND TO THERAPEUTIC ADJUSTMENTS, WITH MEASURED IMPACT ON 30-DAY RE-HOSPITALISATION RATES

Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
4
主要终点
rehospitalization

研究概览

简要总结

Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and reproducible estimation of filling pressures with an evaluation of mitral inflow and the inferior vena cava, allow a more reliable estimate of the true blood volume of the patient and thus lead to a therapeutic adjustment more suitable.

This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30 days and mortality, less alteration of biological parameters myocardial, kidney and liver.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient or his representative must be given free and informed consent and signed consent.
  • The patient must be affiliated or beneficiary of a health insurance plan.
  • The patient is available for a follow-up 6 months.
  • The patient is of age or older (>)
  • Patients hospitalized for acute heart failure who received at least 40mg of furosemide IV.
  • Patient with impaired LVEF <50%.
  • Patient with Nt-proBNP values> 1200pg / ml.

排除标准

  • The subject takes part in another study.
  • The subject is exclusion period determined by a previous study.
  • The subject is under judicial protection.
  • The subject or his representative refuses to sign the consent.
  • It is not possible to give the subject or his representative informed information.
  • Non-inclusion criteria for those diseases or conditions associated (s) interfere (s):
  • The patient is pregnant or is breastfeeding.
  • The patient is already included in a surveillance program (PRADO, OSICAT).
  • Patient with a mechanical or biological mitral prosthesis.
  • History of mitral stenosis.
  • severe valvular surgery with maturity in months (<30 days).
  • chronic renal impairment on dialysis.
  • High grade AV block (AVB and BAV3 2/1).
  • Hypertrophic cardiomyopathy.
  • Cardiogenic shock.
  • Contraindications to furosemide.

研究组 & 干预措施

JET ECHO

Experimental

Transmitral flow estimation

干预措施: Transmitral flow estimation (Procedure)

NO JET ECHO

No Intervention

no bedside echocardiography

结局指标

主要结局

rehospitalization

时间窗: 30 days

次要结局

  • worsening heart failure(during hospitalization)
  • average length of stay(during hospitalization)
  • mortality(6 months)
  • alteration of biological parameters myocardial, kidney and liver(Hospital discharge +7 days, Hospital discharge +30 days)

研究者

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

研究点 (4)

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