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临床试验/NCT03864120
NCT03864120已完成不适用

Understand the Difference Between Clinical Measured Ultrafiltration and Real Ultrafiltration.

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2019年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
261
试验地点
1
主要终点
specific gravity of effluent dialysate is different from water (1g/ml)

研究概览

简要总结

The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been increasingly aware of over the last two decades. There is growing body of observational evidence showing that low UF is related to unfavorable outcome especially in anuric patients. The other side of the problem of UF is excessive fluid removal could volume deplete patients and result in loss of residual renal function and overexposing the membrane to glucose unnecessarily. UF is a double-edged sword. The correct measure of UF is the bottom line of talking about target.

Measuring UF is supposed to be simple and straight forward. The most common way of measuring UF in clinical practice was to weight the effluent bag and minus the manufacture announced fill volume.

Until about 10 years ago, the society first aware that the measurement error in such way is not acceptable. Overfil (the actual volume of dialysate fill in the bag is more than announced) problem was raised from then.

However, there are several other problems around this issue. Firstly, when the product has just been produced overfill is different between manufactory.

Secondly, the overfill volume does change over transportation and storage. But it is not clear how big the change is.

Thirdly, most of the clinics weight the dialysate effluent rather than measure the volume in CAPD, although the specific gravity of dialysate is clearly not going to be 1g/ml.

Taking the fact measuring weight is much easier than measuring volume in CAPD, the question behind is to understand how big the difference is and consequently whether it is acceptable.

All the patients enrolled in the study would be asked to collect all dialysate effluent of the day of their routine peritoneal dialysis adequacy study and bring to the hospital. The exact weight of the bag for PET test (2.5% glucose concentration and dwell time of 4 hour) before and after the dwell and volume measured of the effluent. The dialysate electrolyte, glucose, protein and creatinine level would also be measured.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • on PD treatment for at least one month
  • signed the consent

排除标准

  • Peritonitis or recovery from peritonitis for less than one month.
  • On any intra peritoneal treatment apart from peritoneal dialysis.
  • Evidence of decompensated liver cirrhosis or heart failure.
  • Evidence of extra peritoneal leakage, eg. leakage to thoracic cavity, post peritoneal, hernia.

结局指标

主要结局

specific gravity of effluent dialysate is different from water (1g/ml)

时间窗: For each patient, the outcome would be cross sectional measured at the time the patient does his 6 monthly routine PET test. The data collection time period of the study is 6 month.

To describe the specific gravity of effluent dialysate, the exact weight and volume of effluent dialysate bags in the standard peritoneal equivalent test (PET, 2.5% glucose concentration, 2L, dwell time 4 hours) dwell would be measured in different patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zanzhe Yu

Principal Investigator

RenJi Hospital

研究点 (1)

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