Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Time to clinical stability
研究概览
简要总结
The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life.
Patients hospitalized with ADHF will be asked to follow either a thirst-driven fluid-intake strategy or a fluid-restriction strategy during their hospital stay and for one month after discharge.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Hospitalized for ADHF as the primary diagnosis, meeting both of the following:
- •≥1 documented symptom of new or worsening heart failure (dyspnea, fatigue, decreased exercise tolerance, or symptom of end-organ hypoperfusion).
- •Objective evidence of ADHF, defined as either:
- •i. ≥2 physical signs (edema, ascites, pulmonary rales/crackles, increased JVP, S3 gallop, rapid weight gain due to fluid retention), OR ii. ≥1 physical sign AND ≥1 laboratory finding indicative of ADHF (BNP >500 ng/L or NT-proBNP >2000 ng/L if sinus rhythm, or BNP >750 ng/L or NT-proBNP >3000 ng/L if atrial fibrillation, radiological/ultrasound evidence of pulmonary congestion, echocardiographic sign [VCI >2.1 cm, LVOT VTI <15 cm, E/e' >14, D-dominant pulmonary venous inflow pattern], or invasive evidence [CVP >12 mmHg, PCWP >18 mmHg, CI <2.2 L/min/m2]).
- •Treatment with ≥40 mg IV furosemide (or equivalent)
- •Enrolment within 24 hours of admission
- •Ability to provide informed consent
排除标准
- •Requirement at admission for ICU-level care, or IV inotropic/vasopressor therapy for ADHF.
- •Na+ <125 mmol/L or Na+ >145 mmol/L.
- •End-stage chronic kidney disease on chronic dialysis or eGFR <15 mL/min/1.73 m2
- •Any condition which would make participation unsafe or substantially affect protocol adherence, as judged by investigator.
研究组 & 干预措施
Thirst-driven, liberal fluid intake
干预措施: Thirst-driven, liberal fluid intake (Behavioral)
Fluid restriction
干预措施: Fluid restriction strategy (Behavioral)
结局指标
主要结局
Time to clinical stability
时间窗: From enrollment to 1 month follow-up
Time from randomization to clinical stability. Clinical stability is defined as: 1. Off IV loop diuretics for ≥ 24 hours without need for reinitiation of IV diuretics. 2. No evidence of pulmonary congestion, defined as both: i) No new or worsening dyspnea at rest compared with status at admission ii) Clear lung auscultation or clinically improved, or normal lung and/or vena cava ultrasound without evidence of congestion. 3. No new or worsening peripheral edema compared with status at admission.
次要结局
- Thirst Distress(From enrollment to 1 month follow up)
- Patient-perceived Quality of Life(From enrollment to 1 month follow up)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(From enrollment to 1 month follow up)