NCT03563898

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fluid Overload
• Peritoneal Dialysis Complication

Interventions

Type	Name	Description
OTHER	Sweating with Portable Sauna Bath	Patients will be subjected daily for 30 minutes to the Portable Sauna Care steam bath (45 degree C temperature). The patient will decide if the time and / or temperature of the Sauna Bath is reduced to Tolerance. Before being subjected to the sauna bath, blood pressure will be taken 10 minutes prior. Weigh the patient with a Scale. You will be informed of the symptoms that may occur during the bath, and if present, you will let the health staff know that you will be present at all times during the bathing period, which will have a SURVEILLANCE TABLE which It will be filled during the intervention where they are monitored and comply with the stipulated norms as well as notes for adverse effects. After the completion of the bath, there will be a space of 15 minutes for the patient to dry the skin and the bathing suit with a towel. After 15 minutes, the patient will be weighed and the blood pressure will be taken again.

Timeline

• Start date: 2018-05-28
• Primary completion: 2018-06-06
• Completion: 2018-06-11
• First posted: 2018-06-20
• Last updated: 2018-06-20

Locations

1 site across 1 country: Mexico