Efficacy and Tolerability of Combination Intravenous Diuretic Therapy Versus Intravenous Loop Diuretic Therapy Alone for the Treatment of Acute Decompensated Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Serum Creatinine from Baseline
研究概览
简要总结
Patients with heart failure are often admitted to the hospital because they have accumulated excessive amounts of fluid, they become short of breath and congested with fluid. Removing the excess fluid is necessary to improve the patients symptoms and reduce the risk of being re-admitted to the hospital. Diuretics ("water pills") are often given through an IV to accelerate the fluid removal. Furosemide is commonly used for fluid removal, however some patients do not respond well to the medication. There are other diuretics available that can work in conjunction with furosemide and increase the rate of fluid removal. The other "water pills" have slightly different mechanisms of action in the body compared to furosemide and when combined they may increase fluid removal.
The investigators hypothesize that adding chlorothiazide to furosemide will result in quicker and more effective fluid removal in heart failure patients.
详细描述
The investigators will randomly assign patients to receive either furosemide alone or furosemide in combination with chlorothiazide when they are admitted to the hospital with acute heart failure and excessive volume.
All patients will be monitored for rate of fluid removal, improvement in symptoms, and side-effects of the medications.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Acute Decompensated Heart Failure - by at least 1 symptom (dyspnea, exercise intolerance, weight gain, edema) and at least 1 sign (chest x-ray (CXR), elevated brain natriuretic peptide (BNP), rales, elevated jugular venous pressure (JVP)).
- •History of Congestion Heart Failure (CHF) with chronic loop diuretic use for at least the past 4 weeks
- •Echocardiogram in the past 12 months (to document Ejection fraction (EF))
排除标准
- •Chronic Kidney Disease (CKD) or Acute Kidney Injury (AKI) - Cr >2.5 mg/dL
- •Ventricular assist device
- •Cardiogenic shock
- •Need for mechanical or vasopressor support on admission
- •Significant co-morbidities: Chronic Obstructive Pulmonary Disease, pneumonia, pulmonary embolism
- •History of pulmonary hypertension (PAH) (World Health Organization (WHO) group I primary PAH)
- •Acute Ischemia / post-intervention (Coronary Artery Bypass Graft, Percutaneous Coronary Interventions) in the past 90 days
研究组 & 干预措施
Combination Diuretic Therapy
Patients will receive lasix infusion starting at 5mg/hr along with a bolus dose of chlorothiazide 250mg at the initiation of the protocol. The lasix infusion can be titrated to 10mg after 12hrs based on volume of diuresis. This arm will also receive 250mg bolus doses of chlorothiazide every 12hrs for the duration of the study.
干预措施: Furosemide plus Chlorothiazide (Drug)
Combination Diuretic Therapy
Patients will receive lasix infusion starting at 5mg/hr along with a bolus dose of chlorothiazide 250mg at the initiation of the protocol. The lasix infusion can be titrated to 10mg after 12hrs based on volume of diuresis. This arm will also receive 250mg bolus doses of chlorothiazide every 12hrs for the duration of the study.
干预措施: Furosemide (Drug)
Monotherapy Diuretic
Patients will receive furosemide infusion at 5mg/hr along with an initial bolus dose of furosemide equal to twice their home oral dose. The furosemide infusion can be increased to 10mg/hr after 12hrs based on urine output. This arm will receive bolus doses of furosemide every 12hrs equal to twice their home oral dose until completion of the protocol.
干预措施: Furosemide (Drug)
结局指标
主要结局
Change in Serum Creatinine from Baseline
时间窗: During Index Admission up to 120 hours
Change in serum creatinine from baseline after 72 hours of diuresis
Volume of Diuresis
时间窗: During Index Hospitalization at 72 hours
Total volume of urine output will be collected during the first 72 hours of admission.
次要结局
- Relief of Symptoms(From date of index hospitalization until 72 hours after diuresis)
- Length of Stay(From date of index hospitalization until date of discharge from hospital, assessed up to 1 week)
- Electrolyte Disturbances(From date of index hospitalization until 72 hours after diuresis)
- Hypokalemia(From date of index hospitalization until 72 hours after diuresis)
- Total Weight Loss(From date of index hospitalization until 72 hours after diuresis)
- Potassium Replacement Requirements(From date of index hospitalization until date of discharge from hospital, assessed up to 1 week)
- Adverse Events(From date of index hospitalization until date of discharge from hospital, assessed up to 1 week)