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Fluid OverloadSWEATNCT03563898

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

A study testing Sweating with Portable Sauna Bath in people with Fluid Overload and Peritoneal Dialysis Complication, run by Hospital Civil de Guadalajara at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sweating with Portable Sauna Bath
How many people
10 participants
Where
1 siteMexico
Study dates
28 May 2018to 11 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

PABLO MAGGIANI, resident contact

513335887982

maggiani@gmail.com

JONATHAN CHAVEZ contact

513313299609

Mexico1 site, 1 recruiting

  • Hosptal Civil Fray Antonio Alcalde

    Guadalajara, Jalisco

    JONATHAN CHAVEZ, 513313299609

    Recruiting

Other trials in Mexico

About this study

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

Read the 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.

Being tested
Sweating with Portable Sauna Bath
Medical subject headings
Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sweating with Portable Sauna BathOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through Day 10 of follow up

Secondary outcomes (6)

  1. Degree of overhydration

    The difference at the beginning and the end of overhydration (OH) measured by Bioimpedance, during the duration of the study

    Measured: Through Day 10 of follow up

  2. Decrease in patient's weight

    The difference of median weight (kg) between control and intervention fase during the duration of the study

    Measured: Through Day 10 of follow up

  3. Decrease in blood pressure

    The difference of median systolic/diastolic pressure (mmHg) between control and intervention fase during the duration of the study

    Measured: Through Day 10 of follow up

  4. 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

    Measured: Through Day 10 of follow up

  5. 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

    Measured: Through Day 10 of follow up

  6. Changes in sleep quality

    The difference at the beginning and the end of the Sleep Quality Assessment (PSQI) during the duration of the study

    Measured: Through Day 10 of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start28 May 2018
  3. Primary completion6 Jun 2018
  4. Study completion11 Jun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563898
Sponsor's protocol ID
2222
Acronym
SWEAT
Status last verified
May 2018
First submitted
23 May 2018
Last updated
20 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 36203760

Questions about this trial

What is this clinical trial studying?

A study testing Sweating with Portable Sauna Bath in people with Fluid Overload and Peritoneal Dialysis Complication, run by Hospital Civil de Guadalajara at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact PABLO MAGGIANI, resident (513335887982, maggiani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events (grade 2 or above) as measured by CTCAE v 4.0 (time frame: Through Day 10 of follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563898, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.

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