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
- Conditions
- Peritoneal Dialysis ComplicationFluid Overload
- Registration Number
- NCT03563898
- Lead Sponsor
- Hospital Civil de Guadalajara
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
Being on chronic peritoneal dialysis every day since at least 3 months Diagnostic of Fluid overload Stable clinical condition Written informed consent
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events (grade 2 or above) as measured by CTCAE v 4.0 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
- Secondary Outcome Measures
Name Time Method Decrease in patient's weight Through Day 10 of follow up The difference of median weight (kg) between control and intervention fase during the duration of the study
Decrease in blood pressure Through Day 10 of follow up The difference of median systolic/diastolic pressure (mmHg) between control and intervention fase during the duration of the study
Changes in sleep quality Through Day 10 of follow up The difference at the beginning and the end of the Sleep Quality Assessment (PSQI) during the duration of the study
Decrease in fluid overload symptoms Through Day 10 of follow up The difference at the beginning and the end of The New York Heart Association (NYHA) Functional Classification of breathlessness (during the duration of the study
Degree of overhydration Through Day 10 of follow up The difference at the beginning and the end of overhydration (OH) measured by Bioimpedance, during the duration of the study
Decrease in the control of Urea, Creatinine, phosphorus, potassium and calcium levels Through Day 10 of follow up The difference at the beginning and the end of Urea, Creatinine, phosphorus, potassium and calcium serum levels during the duration of the study
Trial Locations
- Locations (1)
Hosptal Civil Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico