2024-512901-22-00招募中3 期
Utility of intra-abdominal pressure and clinical ultrasound for guiding diuretic treatment in patients with acute heart failure
Fundacion Instituto De Investigacion Sanitaria Aragon14 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 14
- 主要终点
- Congestion absence after the first 72h of intravenous diuretic treatment in hospitalization as determined by the ADVOR scale.
研究概览
简要总结
To evaluate the complete resolution of congestion (ADVOR scale) after the first 72 hours of intravenous diuretic treatment on the hospital ward, between the standard treatment group and the intervention group (intra-abdominal pressure and ultrasound)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women over 18 years of age
- •Diagnosis of HF based on the latest HF guidelines published in 2022
- •NT-proBNP > 1000 pg/mL or BNP > 250 pg/mL
- •Bladder catheterization in order to perform intra-abdominal pressure measurement
- •Intravascular or mixed pattern of congestion, defined as the presence of one or more clinical signs of congestion (edema, ascites and/or pleural effusion)
- •Signature of the informed consent
排除标准
- •Patient with stay in the internal medicine department > 24 hours
- •Systolic blood pressure at admission < 100 mmHg
- •Heart rate at admission > 170 beats per minute (bpm)
- •Cardiogenic shock
- •Acute myocardial ischemia
- •Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
- •Patients whose origin is the Intensive Care Unit
- •Renal transplant recipients
- •Serum hemoglobin < 9 g/dL
- •Pregnancy or lactation
- •Previous history of hypersensitivity to hydrochlorothiazide or furosemide.
- •Patients with recent cardiac surgery (last year) or cardiac transplant recipients
- •Need for inotropic support to maintain adequate cardiac and/or renal output
- •Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization)
- •Patient refusal to participate in the clinical trial
- •Inability or contraindication to bladder catheterization
结局指标
主要结局
Congestion absence after the first 72h of intravenous diuretic treatment in hospitalization as determined by the ADVOR scale.
Congestion absence after the first 72h of intravenous diuretic treatment in hospitalization as determined by the ADVOR scale.
次要结局
未报告次要终点
研究者
Clinical Investigation Unit
Scientific
Fundacion Instituto De Investigacion Sanitaria Aragon
研究点 (14)
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