Efficacy and safety trial of intraperitoneal furosemide in patients on peritoneal dialysis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- efficiency and safety measures
研究概览
简要总结
To study the clinical response to furosemide administered intraperitoneally compared to orally on the hydration status of stable patients in a PD unit.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients on treatment with a daily dose equal to or higher than 120 mg of stable oral furosemide during previous fifteen days .
- •Patients over 18 years of age
- •Clinically stable patients in PD technique
- •Patients with a normofunctioning PD catheter
- •Patients with residual diuresis greater than 500ml per day
- •Patients who have undergone a peritoneal equilibrium test in the previous three months
- •Patients who wish to participate and who sign the informed consent form
排除标准
- •Allergy to furosemide
- •Inability of the patient or caregiver to administer intraperitoneal therapy at home
- •Need to modify the rest of the oral diuretic treatment at the time of inclusion in the study and during follow-up
结局指标
主要结局
efficiency and safety measures
efficiency and safety measures
reduction in body fluid volume
reduction in body fluid volume
weight
weight
blood preasure
blood preasure
presence of oedema
presence of oedema
bioimpedance values
bioimpedance values
ultrasound values (venous excess ultrasound score, VEXUS, and lung ultrasound)
ultrasound values (venous excess ultrasound score, VEXUS, and lung ultrasound)
biochemical markers of congestion: CA125 and NT-proBNP
biochemical markers of congestion: CA125 and NT-proBNP
次要结局
- other measures of interest
- Increased diuresis: 24-hour urine volume, 24-hour urine sodium
研究者
Sandra Beltrán Catalán
Scientific
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana