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临床试验/NCT03563898
NCT03563898Unknown不适用

Feasibility and Safety in the Management of Fluid Overload in Peritoneal Dialysis Patients Through Sweat Stimulation With the Use of Portable Sauna Bath, Pilot Study

Hospital Civil de Guadalajara1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年5月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Number of participants with treatment-related adverse events (grade 2 or above) as measured by CTCAE v 4.0

研究概览

简要总结

The objective of this pilot study is to evaluate the feasibility and safety of the use of diaphoresis achieved through the use of portable sauna baths in peritoneal dialysis patients with fluid overload

详细描述

Fluid overload is a common problem in peritoneal dialysis (PD) patients and it is associated with left ventricular hypertrophy and other adverse cardiac consequences. Fluid management is therefore an important aspect in the management of dialysis patient. Despite improvements in dialysis methods and other techniques in these patients, fluid overload persists due to the great limitations of the affected population: physiopathological, economic, educational, social and psychological. The above creates the need for other therapies that lead to the reduction of overload and thus avoid the comorbidity that this entails. The objective of this study is to evaluate the feasibility and safety of the use of diaphoresis achieved through the use of portable sauna baths in peritoneal dialysis patients with fluid overload. The patients are subjected to a period of data collection for 3 days and then use the portable sauna bath 30 minutes a day supervised by the research team during the 6 following days, without interrupting their peritoneal dialysis therapy. We plan to recruit at least 9 patients with PD with fluid overload. Changes in the degree of overhydration are determined by bioimpedance spectroscopy and patient weight at the beginning and end after treatment. Changes in body weight, blood pressure, potassium, urea and creatinine levels, the degree of edema, as well as knowledge about the salt and liquid line were also evaluated. Adverse events will be reported.

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

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

入选标准

  • Being on chronic peritoneal dialysis every day since at least 3 months Diagnostic of Fluid overload Stable clinical condition Written informed consent

排除标准

  • Any cardiovascular event in the last 12 months (acute myocardial infarction, NYHA Heart Failure III-IV, Cardiac Arrhythmia, Cerebral Vascular Event, Unstable-Stable Angina) Peritonitis Pregnancy

结局指标

主要结局

Number of participants with treatment-related adverse events (grade 2 or above) as measured by CTCAE v 4.0

时间窗: Through Day 10 of follow up

Discontinuation criteria for CTCAE v 4.0 were grade ≥3 adverse events and even grade ≤2 adverse events if the participant wished to withdraw from the study

次要结局

  • Decrease in patient's weight(Through Day 10 of follow up)
  • Decrease in blood pressure(Through Day 10 of follow up)
  • Changes in sleep quality(Through Day 10 of follow up)
  • Decrease in fluid overload symptoms(Through Day 10 of follow up)
  • Degree of overhydration(Through Day 10 of follow up)
  • Decrease in the control of Urea, Creatinine, phosphorus, potassium and calcium levels(Through Day 10 of follow up)

研究者

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

Pablo Maggiani Aguilera

Principal Investigator

Hospital Civil de Guadalajara

研究点 (1)

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