Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fluid Overload
Peritoneal Dialysis Complication
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events (grade 2 or above) as measured by CTCAE v 4.0
timeFrame: Through Day 10 of follow up
Secondary outcomes:
measure: Degree of overhydration
timeFrame: Through Day 10 of follow up
measure: Decrease in patient's weight
timeFrame: Through Day 10 of follow up
measure: Decrease in blood pressure
timeFrame: Through Day 10 of follow up
measure: Decrease in the control of Urea, Creatinine, phosphorus, potassium and calcium levels
timeFrame: Through Day 10 of follow up
measure: Decrease in fluid overload symptoms
timeFrame: Through Day 10 of follow up
measure: Changes in sleep quality
timeFrame: Through Day 10 of follow up
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hosptal Civil Fray Antonio Alcalde
state: Jalisco
Study officials:
References:
citation: Maggiani-Aguilera P, Chavez-Iniguez JS, Navarro-Blackaller G, Hernandez-Morales K, Geraldo-Ozuna AL, Alcantar-Villin L, Montoya-Montoya O, Luquin-Arellano VH, Garcia-Garcia G. Portable sauna stimulated-diaphoresis for the treatment of fluid-overload in peritoneal dialysis patients: A pilot study. Front Med (Lausanne). 2022 Sep 20;9:887609. doi: 10.3389/fmed.2022.887609. eCollection 2022.