The Impact of Slow, Continuous Infusion of Sodium Chloride or Glucose Solution on Diuresis and Urine Composition During Decongestion of Acute Heart Failure Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Urine volume change at individual timepoints during second day of the procedure.
研究概览
简要总结
The aim of the study is to compare the differences in diuretic, natriuretic and clinical response to decongestion in patients receiving different replacement fluid regimens (0.9% sodium chloride vs 5% glucose) in acute heart failure.
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 (Participant)
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 >18 years old who sign the informed consent
- •the primary cause of hospitalization is Acute Heart Failure with a need for intravenous Furosemide
- •the start of the study within 24h of hospital admission
排除标准
- •need for inotropic support
- •end stage renal disease on dialysis
- •serum sodium > 148mmol/l or < 130 mmol/l.
研究组 & 干预措施
0.9 % Sodium Chloride solution
Patients receiving an intravenous infusion of 0.9% NaCl
干预措施: Furosemide intravenous infusion (Drug)
0.9 % Sodium Chloride solution
Patients receiving an intravenous infusion of 0.9% NaCl
干预措施: Continous intravenous infusion of 0.9% Sodium Chloride solution (Drug)
5% Glucose solution
Patients receiving an intravenous infusion of 5% glucose
干预措施: Furosemide intravenous infusion (Drug)
5% Glucose solution
Patients receiving an intravenous infusion of 5% glucose
干预措施: Continous intravenous infusion of 5% Glucose solution (Drug)
结局指标
主要结局
Urine volume change at individual timepoints during second day of the procedure.
时间窗: 48 hours
Comparison of urine volume between the groups at individual timepoints during the second day of the procedure.
Urine volume change at individual timepoints during first day of the procedure.
时间窗: 24 hours
Comparison of urine volume between the groups at individual timepoints during the first day of the procedure.
Total dose of furosemide.
时间窗: 48 hours
Comparison of the total dose of furosemide between the groups at hours.
Urine composition at individual time points.
时间窗: 72 hours
Comparison of urine composition (urinary sodium and urinary chloride) between the groups and its change during 72h
Cumulative urine output at 24 hours.
时间窗: 24 hours
Comparison of cumulative urine output between the groups at 24 hours.
Cumulative urine output at hours.
时间窗: 48 hours
Comparison of cumulative urine output between the groups at 48 hours.
次要结局
- Total time on intravenous furosemide.(3 months)
- Renin-Angiotensin-Aldosterone system activity.(48 hours)
- Heart Failure rehospitalization(30 days)
研究者
Gracjan Iwanek
Medical Doctor
Wroclaw Medical University