Transfer and Ultrafiltration In Peritoneal Dialysis (TULIPE)
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Franche-Comté
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Besançon、Franche-Comté、法国、25000
- Besançon University Hospital, Nephrology Department
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients hospitalized in the Nephrology department of the Besançon University Hospital
- Patients treated by continuous ambulatory peritoneal dialysis or ambulatory peritoneal dialysis for at least 6 months
- Absence of hospitalization caused by an infection in the month prior to inclusion
- Patients with a ratio (D / P) of the concentration of creatinine in the blood and dialysate between 0.5 and 0.8 on a checkup of less than 1 year.
- No contraindication to the use of hypertonic bag
- Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study
- Affiliation to a French social security system or beneficiary
Exclusion Criteria:
- Legal incapacity or limited legal capacity
- Patients unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
- Patients without health insurance
- Pregnant women
- Patient being in the exclusion period from another study or planned by the "national register of volunteers"
- Hospitalization caused by an infection in the month prior to inclusion
- Patients with a peritoneal dialysis catheter dysfunction
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：conventional scheme followed by alternate schem
The first day of the study, patients receive an adapted conventional peritoneal dialysis scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²). The second day, patients receive an adapted and alternate scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once. |
Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle).
A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.
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实验性的：alternate scheme followed by conventional scheme
The first day of the study, patients receive an adapted and alternate peritoneal dialysis scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once. The second day, patients receive an adapted conventional scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²). |
Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle).
A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)
大体时间：In a maximum of 72 hours after collection
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In a maximum of 72 hours after collection
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合作者和调查者
调查人员
- 首席研究员：Cécile Courivaud, MCU/PH、Besançon University Hospital, Nephrology Department
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.