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 (SWEAT)

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

Study Overview

• Status: Unknown
• Conditions: Fluid Overload; Peritoneal Dialysis Complication
• Intervention / Treatment: Other: Sweating with Portable Sauna Bath

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Recruiting
      • Hosptal Civil Fray Antonio Alcalde
      • Contact: JONATHAN CHAVEZ; Phone Number: 513313299609

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospital Civil de Guadalajara

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2018
• Primary Completion (ACTUAL): June 6, 2018
• Study Completion (ANTICIPATED): June 11, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No