Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Sweating
• Intervention / Treatment: Behavioral: water immersion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: manar salah; Phone Number: 01092058750; Email: manarsalah303@gmail.com
• Study Contact Backup: Name: khalid Ali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chronic kidney disease patients stage 3 and 4; 50 chronic kidney disease patients stage 3 and 4 will perform mild exercise and water immersion	Behavioral: water immersion; mild physical activity then water immersion in tub

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
assess improvement of blood pressure	follow up blood pressure (systolic and diastolic blood pressure in mm hg)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of improvement in serum potassium level	measure potassium level in mmol\L with weekly follow up	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Ashraf Elshazly, professor, professor

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 21, 2023
• Primary Completion (Anticipated): June 21, 2024
• Study Completion (Anticipated): June 21, 2025

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 13, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: alternative HDF in CKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study design results
• IPD Sharing Time Frame: 2 to 3 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No