NCT05861219

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2025

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

April 27, 2023

Last Update Submit

May 13, 2023

Conditions

Sweating

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • assessment of improvement in serum potassium level

    1 year

Study Arms (1)

chronic kidney disease patients stage 3 and 4

EXPERIMENTAL

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

Behavioral: water immersion

Interventions

water immersionBEHAVIORAL

mild physical activity then water immersion in tub

chronic kidney disease patients stage 3 and 4

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic kidney disease group:
  • stage 3,4
  • Age(18-60)yrs old.
  • Not on dialysis.
  • Without uremic symptoms nor standard indication for dialysis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

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

    PMID: 26344507BACKGROUND

  • 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.

    PMID: 31608304BACKGROUND

  • 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.

    PMID: 12817713BACKGROUND

  • 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.

    PMID: 6693781BACKGROUND

  • 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.

    PMID: 27699485BACKGROUND

  • 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.

    PMID: 9373914BACKGROUND

Study Officials

  • Ashraf Elshazly, professor

    professor

    STUDY CHAIR

Central Study Contacts

manar salah

CONTACT

01092058750manarsalah303@gmail.com

khalid Ali

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Chronic kidney disease stage 3,4
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 16, 2023

Study Start

June 21, 2023

Primary Completion

June 21, 2024

Study Completion

June 21, 2025

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

study design results

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
2 to 3 years