Continuous Versus Bolus Intermittent Loop Diuretic Infusion in Acutely Decompensated Heart Failure: Evaluation of Renal Function, Congestion Signs, BNP and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 370
- 试验地点
- 4
- 主要终点
- Cardiac death and rehospitalization for HF
研究概览
简要总结
DiurHF is a prospective, multicenter, observational, study that compares continuous with intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous pilot study design was planned to anticipate a larger multicenter trial able to definitively evaluate the optimal loop diuretic use strategy in patients with ADHF.
详细描述
The use of intravenous loop diuretics is a cornerstone of therapy for acutely decompensated heart failure (ADHF); significant concerns have been raised regarding risks and benefits of loop diuretics, particularly about dosage and administration regimen.
Recent guidelines recommend the use of these drugs to reduce left ventricular filling pressure, avoid pulmonary edema, and alleviate peripheral fluid retention.
Some studies have provided guidelines for the administration of these drugs in clinical practice, but data interpretation remains challenging due to the frequent exclusion of patients with kidney disease from major ADHF clinical trials. Therefore, it is not clear if continuous infusion is better than intermittent boluses in terms of decongestion, maintenance of renal filtration function and prognosis.
On the other hand, continuous administration should provide a more constant delivery of the drug into the tubule, potentially reducing these phenomena.
The aim of the study is to evaluate the better loop diuretic intravenous administration in terms of renal function, congestion signs, BNP and outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients over 18 years;
- •Patients with diagnosis of ADHF(dyspnea, orthopnea, peripheral edema or major fatigue and at least two clinical signs including rales, hepatomegaly, pulmonary congestion on chest radiography, jugular vein dilatation, or a third heart sound);
- •Blood BNP > 100 pg/mL;
- •ADHF: Acute Decompensated Heart Failure; BNP: B-type Natriuretic Peptide; IV: IntraVenous; LVEF: Left Ventricular Ejection Fraction.
排除标准
- •Patients who receive more than 40 mg of IV furosemide;
- •End-Stage renal disease or renal replacement therapy;
- •Recent myocardial infarction (within thirty days of screening);
- •Systolic blood pressure < 80 mmHg;
- •Creatinine levels > 4 mg/dL;
- •Patients affected by sepsis, liver diseases, inflammatory diseases or neoplastic diseases.
研究组 & 干预措施
Continuous Furosemide Infusion
continuous intravenous furosemide infusion
干预措施: Continuous Furosemide Infusion (Drug)
Intermittent Furosemide Infusion
bolus intermittent intravenous furosemide infusion
干预措施: Intermittent Furosemide Infusion (Drug)
结局指标
主要结局
Cardiac death and rehospitalization for HF
时间窗: 180 days
Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge.
次要结局
- Body weight changes(from admission to discharge (7-12 days))
- Acute kidney injury(From date of randomization until the discharge (7-12 days))
- length of hospital stay (days)(From date of randomization until the discharge (7-12 days))
- Inotropes agents(From date of randomization until the discharge (7-12 days))
- hypertonic saline solution(From date of randomization until the discharge (7-12 days))
- Diuresis(from admission to discharge (7-12 days))
- BNP changes(From date of randomization until the discharge (7-12 days))
- BUN changes(From date of randomization until the discharge (7-12 days))
- Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide)(180 days)
- Reduction of edema(From date of randomization until the discharge (7-12 days))
- Reduction of dyspnea(From date of randomization until the discharge (7-12 days))
- High (> 125 mg/die) versus low (<125 mg/die) intravenous diuretic dosage(180 days)
- Regression of pulmonary congestion(From date of randomization)
研究者
Alberto Palazzuoli MD PhD
Medical Doctor, Cardiologist
University of Siena