Clinical trial NCT05861219: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sweating
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Chronic kidney disease stage 3,4
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

chronic kidney disease group:

1. stage 3,4
2. Age(18-60)yrs old.
3. Not on dialysis.
4. Without uremic symptoms nor standard indication for dialysis

Exclusion Criteria:

1. History of cerebrovascular accidents.
2. History of advanced cardiac disease (heart failure, recent acute coronary syndrome, and cardiac arrhythmia).
3. Active skin lesion
4. volume overload. 5- advanced liver cirrhosis, respiratory failure, and malignancy.

Primary outcomes:
measure: assessment of improvement of kidney function test( urea and creatinine)
timeFrame: 1 year
measure: assess improvement of blood pressure
timeFrame: 1 year
Secondary outcomes:
measure: assessment of improvement in serum potassium level
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: professor
name: Ashraf Elshazly, professor
role: STUDY_CHAIR
References:
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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.
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.
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.
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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.