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
About this trial
This is an interventional screening trial for Sweating
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.
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
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
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Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients
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