Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients

Sweating Clinical Trial

Official title:

Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861219
• Other study ID #: alternative HDF in CKD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: June 21, 2025

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: manar salah
• Phone: 01092058750
• Email: manarsalah303[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 21, 2025
• Est. primary completion date: June 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic
• Sweating

Intervention

Behavioral:
• water immersion
mild physical activity then water immersion in tub

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Ronco C. Hemodiafiltration: Technical and Clinical Issues. Blood Purif. 2015;40 Suppl 1:2-11. doi: 10.1159/000437403. Epub 2015 Sep 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	assess improvement of blood pressure	follow up blood pressure (systolic and diastolic blood pressure in mm hg)	1 year
Secondary	assessment of improvement in serum potassium level	measure potassium level in mmol\L with weekly follow up	1 year