A Performance Analysis of the Peritoneal Ultrafiltration (PUF) Achieved With the Carry Life® UF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Triomed AB
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Ultrafiltration volume
研究概览
简要总结
The Carry Life UF device performs peritoneal ultrafiltration by adding a concentrated glucose to peritoneal dialysis fluid which has been instilled into the abdomen prior to the connection of the device. Maintaining the glucose concentration in the intraperitoneal fluid results in an increased fluid removal (ultrafiltration).
The clinical investigation will evaluate the ultrafiltration achieved with the Carry Life UF device compared to standard peritoneal dialysis (PD) therapy
详细描述
A study of the peritoneal ultrafiltration achieved with Carry Life® UF compared to standard PD therapy, performed in 12 stable PD patients. The study consists of one baseline study session with Icodextrin overnight and one four-hour, 2.27% glucose exchange and three Carry Life® UF treatments with different glucose doses. All treatments are preceded by an Icodextrin dwell overnight.
Visit 1: The patient will be screened for study eligibility and a signed informed consent obtained before any of the study activities commence. Once included in the study the patient will be asked to document their ultrafiltration volumes for the week prior to the baseline study session (PD bags to be weighed before and after).
Visit 2: Baseline study session with standard PD therapy. The evening before visit 2 the patient will use Icodextrin 2000 ml overnight which is drained at the clinic before the start of the second PD exchange.
- A four-hour dwell with 2.27%, 2000 ml PD fluid will be performed at the clinic.
- During the study sessions the fluid intake and output will be measured.
- A 24 h urine collection for urea and creatinine clearance started the day before the baseline study session will be completed at the baseline study session.
Visit 3, 4 and 5: Carry Life® UF study sessions The evening before the visits the patient will use Icodextrin 2000 ml overnight which is drained at the clinic the next day before the start of the Carry Life® UF study session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Male or female
- •On stable PD including Icodextrin, treated at the clinic for at least 3 months
- •No clinical signs of dehydration.
- •Obtained written consent to participate in the study
排除标准
- •Significant illness or active infection (evaluated by clinical examination) in the past 4 weeks
- •Episodes of peritonitis during the past 2 months
- •Active malignant disease
- •Diabetes type 1
- •Abdominal hernias
- •HIV and/or hepatitis positive within the last 3 months
- •Known pregnancy or breastfeeding and pregnancy test for women of child bearing age.
- •Conditions deemed by investigator as inappropriate for participation
- •Participation in clinical trials, interfering with the present study, one month prior to inclusion
研究组 & 干预措施
Single arm
Single arm in which everyone enrolled in a trial receives treatment with Carry Life UF device,
干预措施: Carry Life UF device (Device)
结局指标
主要结局
Ultrafiltration volume
时间窗: During a five hour study session
The ultrafiltration volumes achieved during the study sessions
次要结局
未报告次要终点