Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing With Furosemide: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 24-Hour Urine Output
研究概览
简要总结
The purpose of this study is to examine whether administering metolazone 60 minutes prior to furosemide increases urine output compared with administering metolazone and furosemide concomitantly. Participants will have equal chance of being assigned to each group.
详细描述
Diuretic resistance is common among patients with acute decompensated heart failure, and one strategy for overcoming this phenomenon is sequential nephron blockade with loop plus thiazide-type diuretics. Metolazone is an oral thiazide-type diuretic commonly used for this purpose. Due to its delayed absorption, some clinicians suggest that metolazone be given 30-60 minutes prior to the loop diuretic. However, the efficacy and safety of such a strategy has not been investigated despite its added complexity. The purpose of this study is to investigate whether pre-dosing with metolazone confers a difference in efficacy and safety compared to administering it at the same time as furosemide.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission within 48 hours for acute decompensated heart failure with at least one symptom and one sign of volume overload
- •Receipt of loop diuretic prior to admission
- •Plan to administer furosemide 120 - 160 mg IV bolus twice daily over the next 24 hours with additional diuresis deemed necessary
- •If patient is concurrently administered intravenous vasodilator or inotrope, the dose of vasodilator or inotrope must be stable for 6 hours prior to enrollment with a plan to continue the same dose for the 24 hour duration of this study
排除标准
- •Metolazone prescribed prior to admission
- •Receipt of continuous intravenous infusion of furosemide
- •Cirrhosis or end stage renal disease
- •Non-English speaking patients
研究组 & 干预措施
Metolazone Pre-dosing
Metolazone 5 mg by mouth administered 60 minutes prior to furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)
干预措施: Metolazone 60 minutes prior to furosemide (Drug)
Metolazone Concurrent Dosing
Metolazone 5 mg by mouth administered at the same time as furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)
干预措施: Metolazone concurrently with furosemide (Drug)
结局指标
主要结局
24-Hour Urine Output
时间窗: 24 hours
Total measured urine output in milliliters produced after metolazone dose is given
次要结局
- Change in Serum Creatinine(Baseline and at 12 to 23 hours after metolazone dose)
- Hypokalemia(Baseline and at 12 to 23 hours after metolazone dose)
- Hyponatremia(Baseline and at 12 to 23 hours after metolazone dose)
- Change in Total Body Weight(Baseline and at 12 to 23 hours after metolazone dose)
- Hypomagnesemia(Baseline and at 12 to 23 hours after metolazone dose)
- Acute Kidney Injury(Baseline and at 12 to 23 hours after metolazone dose)
研究者
Brent Reed
Associate Professor, Pharmacy Practice and Science
University of Maryland, Baltimore