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临床试验/NCT05807152
NCT05807152招募中不适用

Furosemide-induced Diuresis With Matched Dehydration Compared to Standard Diuretic Therapy in Acute Heart Failure and Overt Fluid Overload

Centro Cardiologico Monzino2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年2月19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
170
试验地点
2
主要终点
Daily serum creatinine measurement during study treatment for assessment of acute kidney injury occurrence

研究概览

简要总结

Acute decompensated heart failure (ADHF) is a complex clinical syndrome caused by cardiac abnormalities compromising the ability of the heart to provide a blood supply adequate to the metabolic needs of peripheral tissues. ADHF is characterized by systemic and pulmonary fluid retention, with weight gain, peripheral edema, needing diuretic therapy. Moreover, ADHF is associated with neurohormonal hyper-activation with enhanced sympathetic nervous and renin-angiotensin-aldosterone systems stimulation, that sustain the vicious circle of cardiac dysfunction and fluid retention.

The administration of high doses of diuretics, usually required in ADHF treatment, can induce hypovolemia-induced neurohormonal activation and transient deterioration of kidney function, that, in turn, counteracts the effect of diuretics and limits recovery from fluid overload.

The investigators hypothesized that, in patients with ADHF, a more controlled and physiologically-oriented dehydration may blunt diuretic-associated neurohormonal activation, thus providing a safer and more sustained clinical benefit. This controlled dehydration can be achieved by combining furosemide with the RenalGuard System (see The RenalGuard™ System Operator's Manual for specific instructions in setting up and running the device). To date, no data have been provided regarding the potential beneficial effect of this therapeutic strategy in patients with ADHF and fluid overload. Much of the evidences on the use of the RenalGuard system comes from the clinical setting of acute kidney injury (AKI) prevention in patients undergoing intravascular contrast exposure. In this specific field, furosemide-induced high-volume diuresis with concurrent maintenance of intravascular volume through matched hydration, by the RenalGuard System, is now considered by current Guidelines a recommended strategy for AKI prevention in patients with chronic renal failure undergoing coronary interventional procedures. Based on this experience, the investigators will assess the safety and efficacy of this known system capable of delivering intravenous fluid in an amount exactly pre-determined, considering the volume of urine produced by the patient and precisely weighed by the system. This could prevent hypovolemia that may occur in response to high-volume diuresis induced by furosemide. The researchers will perform a spontaneous, prospective, randomized trial aiming at investigating the effect of combined furosemide-induced diuresis and automated matched dehydration, compared with standard furosemide administration in ADHF patients with fluid overload.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years of age
  • New York Heart Association (NYHA) functional class III or IV
  • estimated weight gain due to peripheral fluid overload >4 kg
  • admission BNP values >400 pg/ml if in sinus rhythm and >600 pg/ml if in atrial fibrillation

排除标准

  • inability to provide informed consent
  • acute pulmonary edema, cardiogenic shock
  • end-stage renal disease (Stage V) or need for renal replacement therapy
  • ongoing treatment with Entresto (BNP not reliable)
  • need for inotropic/vasopressor drug support
  • contraindications to placement of a Foley catheter.
  • Known hypersensitivity to furosemide

结局指标

主要结局

Daily serum creatinine measurement during study treatment for assessment of acute kidney injury occurrence

时间窗: Daily, up to 72 hours

Blood sample for creatinine evaluation will be performed daily

次要结局

  • Daily weight decrease during study treatment(Daily, up to 72 hours)

研究者

发起方
Centro Cardiologico Monzino
申办方类型
Other
责任方
Principal Investigator
主要研究者

Piergiuseppe Agostoni

Professor

Centro Cardiologico Monzino

研究点 (2)

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