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)

June 19, 2018 updated by: Pablo Maggiani Aguilera, Hospital Civil de Guadalajara
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: JONATHAN CHAVEZ
  • Phone Number: 513313299609

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Through Day 10 of follow up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Degree of overhydration
Time Frame: Through Day 10 of follow up
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
Time Frame: Through Day 10 of follow up
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
Time Frame: Through Day 10 of follow up
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
Time Frame: Through Day 10 of follow up
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
Time Frame: Through Day 10 of follow up
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
Time Frame: Through Day 10 of follow up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Civil de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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