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

Fluid Overload Clinical Trial

— SWEAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563898
• Other study ID #: 2222
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: June 11, 2018

Study information

• Verified date: May 2018
• Source: Hospital Civil de Guadalajara
• Contact: PABLO MAGGIANI, resident
• Phone: 513335887982
• Email: maggiani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 11, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fluid Overload
• Peritoneal Dialysis Complication

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hosptal Civil Fray Antonio Alcalde	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events (grade 2 or above) as measured by CTCAE v 4.0	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	Through Day 10 of follow up
Secondary	Degree of overhydration	The difference at the beginning and the end of overhydration (OH) measured by Bioimpedance, during the duration of the study	Through Day 10 of follow up
Secondary	Decrease in patient's weight	The difference of median weight (kg) between control and intervention fase during the duration of the study	Through Day 10 of follow up
Secondary	Decrease in blood pressure	The difference of median systolic/diastolic pressure (mmHg) between control and intervention fase during the duration of the study	Through Day 10 of follow up
Secondary	Decrease in the control of Urea, Creatinine, phosphorus, potassium and calcium levels	The difference at the beginning and the end of Urea, Creatinine, phosphorus, potassium and calcium serum levels during the duration of the study	Through Day 10 of follow up
Secondary	Decrease in fluid overload symptoms	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	Through Day 10 of follow up
Secondary	Changes in sleep quality	The difference at the beginning and the end of the Sleep Quality Assessment (PSQI) during the duration of the study	Through Day 10 of follow up