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

NCT03563898 | Unknown

• 1 other identifier: 2222
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Fluid Overload; Peritoneal Dialysis Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Degree of overhydration

  Through Day 10 of follow up

• Decrease in patient's weight

  Through Day 10 of follow up

• Decrease in blood pressure

  Through Day 10 of follow up

• Decrease in the control of Urea, Creatinine, phosphorus, potassium and calcium levels

  Through Day 10 of follow up

• Decrease in fluid overload symptoms

  Through Day 10 of follow up

Interventions

Sweating with Portable Sauna Bath OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hosptal Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

RECRUITING

Related Publications (1)

• 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.

  PMID: 36203760 DERIVED

MeSH Terms

Conditions

Edema

Interventions

Sweating

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Temperature Regulation; Body Temperature; Physiological Phenomena; Homeostasis; Skin Physiological Phenomena; Integumentary System Physiological Phenomena; Adaptation, Physiological; Adaptation, Biological; Biological Phenomena

Central Study Contacts

PABLO MAGGIANI, resident

CONTACT

513335887982; maggiani@gmail.com

JONATHAN CHAVEZ

CONTACT

513313299609

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 20, 2018
• Study Start: May 28, 2018
• Primary Completion: June 6, 2018
• Study Completion: June 11, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-05

Locations

ME (1)