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Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients

Primary Purpose

Sweating

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
water immersion
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sweating

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: chronic kidney disease group: stage 3,4 Age(18-60)yrs old. Not on dialysis. Without uremic symptoms nor standard indication for dialysis Exclusion Criteria: History of cerebrovascular accidents. History of advanced cardiac disease (heart failure, recent acute coronary syndrome, and cardiac arrhythmia). Active skin lesion volume overload. 5- advanced liver cirrhosis, respiratory failure, and malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    chronic kidney disease patients stage 3 and 4

    Arm Description

    50 chronic kidney disease patients stage 3 and 4 will perform mild exercise and water immersion

    Outcomes

    Primary Outcome Measures

    assessment of improvement of kidney function test( urea and creatinine)
    kidney function test (serum urea and creatinine im mg\dl) will measured before the procedure with weekly follow up
    assess improvement of blood pressure
    follow up blood pressure (systolic and diastolic blood pressure in mm hg)

    Secondary Outcome Measures

    assessment of improvement in serum potassium level
    measure potassium level in mmol\L with weekly follow up

    Full Information

    First Posted
    April 27, 2023
    Last Updated
    May 13, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05861219
    Brief Title
    Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients
    Official Title
    Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 21, 2023 (Anticipated)
    Primary Completion Date
    June 21, 2024 (Anticipated)
    Study Completion Date
    June 21, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Hemodiafiltration is a renal replacement technique combining diffusion and convection to enhance solute removal. Post dialyser replacement fluid is administered to achieve the target fluid balance. The skin is the largest human organ playing an important role in thermal and Na regulation and skin blood flow is 8.5-10%of cardiac output .
    Detailed Description
    Sweat contains electrolytes, creatinine and urea, with higher excretion by mild physical exercise. These findings motivate studies investigating the effect of stimulated sweating on volume control in kidney disease patients. Using sweat as the vehicle for removing molecules normally excreted in the urine was identified some decades ago. sweat urea concentration could reach 5.5 to 50 times the serum concentration . Physical inactivity was reported as the fourth leading cause of death from chronic disease worldwide. Warm water immersion (37-46◦C) increases limb blood flow, and muscle heating activates regulators of mitochondrial biogenesis. water immersion represent diffusion .the average person sweats between (0.8- 1.4) liters during an hour of exercise, drinking water represent water replacement . Particularly, urea concentrations in sweat are persistently elevated in uremic patients. The 24-hour urinary urea excretion in summer was 1/4 the quantity in winter in uremic patients, indicating the compensatory urea excretion in sweat gland fluid . Sweat glands are inactive except above 29°C, due to a concentration gradient within the stratum corneum, results in continuous water convection from within the body through the skin and into the environment. In our study we stimulate sweating of chronic kidney disease patients through mild physical activity as walking then they immersied in water to enhance waste excretion through skin.Evaluation of these patients will be done through following up blood pressure,laboratory investigations as kidney function test sodium, potassium,phosphorus levels and uric acid.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sweating

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Chronic kidney disease stage 3,4
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    chronic kidney disease patients stage 3 and 4
    Arm Type
    Experimental
    Arm Description
    50 chronic kidney disease patients stage 3 and 4 will perform mild exercise and water immersion
    Intervention Type
    Behavioral
    Intervention Name(s)
    water immersion
    Intervention Description
    mild physical activity then water immersion in tub
    Primary Outcome Measure Information:
    Title
    assessment of improvement of kidney function test( urea and creatinine)
    Description
    kidney function test (serum urea and creatinine im mg\dl) will measured before the procedure with weekly follow up
    Time Frame
    1 year
    Title
    assess improvement of blood pressure
    Description
    follow up blood pressure (systolic and diastolic blood pressure in mm hg)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    assessment of improvement in serum potassium level
    Description
    measure potassium level in mmol\L with weekly follow up
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic kidney disease group: stage 3,4 Age(18-60)yrs old. Not on dialysis. Without uremic symptoms nor standard indication for dialysis Exclusion Criteria: History of cerebrovascular accidents. History of advanced cardiac disease (heart failure, recent acute coronary syndrome, and cardiac arrhythmia). Active skin lesion volume overload. 5- advanced liver cirrhosis, respiratory failure, and malignancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    manar salah
    Phone
    01092058750
    Email
    manarsalah303@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    khalid Ali
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashraf Elshazly, professor
    Organizational Affiliation
    professor
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    study design results
    IPD Sharing Time Frame
    2 to 3 years
    Citations:
    PubMed Identifier
    26344507
    Citation
    Ronco C. Hemodiafiltration: Technical and Clinical Issues. Blood Purif. 2015;40 Suppl 1:2-11. doi: 10.1159/000437403. Epub 2015 Sep 8.
    Results Reference
    background
    PubMed Identifier
    31608304
    Citation
    Baker LB. Physiology of sweat gland function: The roles of sweating and sweat composition in human health. Temperature (Austin). 2019 Jul 17;6(3):211-259. doi: 10.1080/23328940.2019.1632145. eCollection 2019.
    Results Reference
    background
    PubMed Identifier
    12817713
    Citation
    Huang CT, Chen ML, Huang LL, Mao IF. Uric acid and urea in human sweat. Chin J Physiol. 2002 Sep 30;45(3):109-15.
    Results Reference
    background
    PubMed Identifier
    6693781
    Citation
    Blank IH, Moloney J 3rd, Emslie AG, Simon I, Apt C. The diffusion of water across the stratum corneum as a function of its water content. J Invest Dermatol. 1984 Feb;82(2):188-94. doi: 10.1111/1523-1747.ep12259835.
    Results Reference
    background
    PubMed Identifier
    27699485
    Citation
    Joo CH, Allan R, Drust B, Close GL, Jeong TS, Bartlett JD, Mawhinney C, Louhelainen J, Morton JP, Gregson W. Passive and post-exercise cold-water immersion augments PGC-1alpha and VEGF expression in human skeletal muscle. Eur J Appl Physiol. 2016 Dec;116(11-12):2315-2326. doi: 10.1007/s00421-016-3480-1. Epub 2016 Oct 3.
    Results Reference
    background
    PubMed Identifier
    9373914
    Citation
    al-Tamer YY, Hadi EA, al-Badrani II. Sweat urea, uric acid and creatinine concentrations in uraemic patients. Urol Res. 1997;25(5):337-40. doi: 10.1007/BF01294662.
    Results Reference
    background

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    Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients

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