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Dermodialysis as Adjuvant Therapy in Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03810989
Recruitment Status : Unknown
Verified January 2019 by Yasser Abd Elmawgood Fysal Ibrahim, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : January 22, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yasser Abd Elmawgood Fysal Ibrahim, Assiut University

Brief Summary:
Using sweat as the vehicle for removing molecules normally excreted in the urine(dermodialysis) was identified some decades ago.The study will include 66 ESRD patients and 20 CKD stage 5 patients not on dialysis who met inclusion and exclusion criteria. The ESRD patients will be divided into three groups and will be subjected to different modalities of stimulation of sweating like infra-red sauna , physical exercise and hot bath. The study will be conducted over a period of three months. During the first month, patients were dialyzed as usual (control phase).During the next two months ,the participants will be dialysed twice weekly in addition to dermodialysis. S Cr, BUN, serum K and serum phosphorus will be measured weekly immediately before the last dialysis session during the control and intervention phases. The mean of this investigations during each phase will be calculated . The investigators will compare the mean of this investigations during control phase with the mean during the intervention phase to evaluate the effectiveness of dermodialysis as adjuvant therapy for ESRD patients.The patients not on dialysis will subjected to infra-red sauna and hot bath.The investigators also will compare the means of S Cr, BUN, serum K and serum phosphorus during both control and intervention phases like the ESRD patients.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Device: infra-red sauna Device: argometer and treadmill Device: combination of sauna and hot bath Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: the same groups of patients will be used for the experimental and control groups (self controlled study or time series study).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using of the Skin as a Third Spare Kidney for Patients With Chronic Renal Failure
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Experimental: infra-red sauna
During the intervention phase, the patient will be dialysed twice weekly on Saturday and Wednesday. During the in-between three days, the patients will be subjected to an intervention as the following :- three session of infra-red sauna of 15 minutes duration separated by ten minutes rest outside the sauna.
Device: infra-red sauna
During the intervention phase, the ESRD patients twill be subjected to a method of stimulation of sweating as the following :- three session of infra-red sauna of 15 minutes duration separated by ten minutes rest outside the sauna.

Experimental: argometer and treadmill
During the intervention phase, the patient will be dialysed twice weekly on Saturday and Wednesday. During the in-between three days, the patients will be subjected to an intervention as the following :- three session of physical exercise (by treadmill and argometer) of 20-30 minutes duration separated by 10 minutes rest.
Device: argometer and treadmill
During the intervention phase, the ESRD patients twill be subjected to a method of stimulation of sweating as the following :- three session of physical exercise (by treadmill and argometer) of 20-30 minutes duration separated by 10 minutes rest.

Experimental: combination of sauna and hot bath
During the intervention phase, the patient will be dialysed twice weekly on Saturday and Wednesday. During the in-between three days, the patients will be subjected to an intervention as the following :- three session of infra-red sauna as the first group then the patients will be immersed up to neck for one hour in water at 37-43 C.
Device: combination of sauna and hot bath
During the intervention phase, the ESRD patients twill be subjected to a method of stimulation of sweating as the following :- three session of infra-red sauna as the first group then the patients will be immersed up to neck for one hour in water at 37-43 C.

Experimental: combination of sauna and hot bath in CKD
During the first month (control phase), S Cr, BUN, serum K and serum phosphorus will be measured weekly and the mean will be calculated. During the next two months (intervention phase) the patient will be subjected to three session of sauna of 15 minutes duration separated by ten minutes rest outside the sauna then the patients will be immersed up to neck for one hour in water at 37 -43 C .
Device: combination of sauna and hot bath
During the intervention phase, the ESRD patients twill be subjected to a method of stimulation of sweating as the following :- three session of infra-red sauna as the first group then the patients will be immersed up to neck for one hour in water at 37-43 C.




Primary Outcome Measures :
  1. change in the mean of BUN, serum Cr, serum k and serum phosphorus . [ Time Frame: 3months ]
    S Cr, BUN, serum K and serum phosphorus will be measured weekly immediately before the last dialysis session during the control and intervention phases. The mean of this investigations during each phase will be calculated .The investigators will compare the mean of this investigations during control phase with the mean during the intervention phase to evaluate the effectiveness of dermodialysis as adjuvant therapy for ESRD patients.

  2. change in interdialytic weight gain(IDWG) [ Time Frame: 3months ]
    interdialytic weight gain(IDWG)=weight of the patients before the dialysis session minus his weight immediately after the previous session. The mean of IDWG will be calculated during both the control and intervention phases ,then The investigators will compare both means.


Secondary Outcome Measures :
  1. The effect on uremic pruritus [ Time Frame: 3 months ]
    Assessment of uremic pruritus according to verbal rating scale (VRS) during both control and intervention phases . Verbal rating scale (VRS)which divided into four level:-0=no symptom, 1=mild, 2= moderate, 3=sever or intense symptom.the investigators will compare the severity of uremic pruritus in the two phases.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A-chronic renal failure groups:-

    1. Patients with chronic renal failure on regular haemodialysis three times a week.
    2. starting regular haemodialysis at least 6 months before the beginning of the study.
    3. Ability to perform physical exercise in argometer and treadmill arm.
  • B-chronic kidney disease(CKD) group:

    • 1- CKD stage 5 (eGFR 10-15ml /min calculated by EPI equation).

      2-Not on dialysis.

      3-Without uremic symptoms nor standard indication for dialysis according to KDOQI guide lines.

Exclusion Criteria:

  • A-ESRD groups:-

    1. Having temporary or tunneled catheter as modality of vascular access.
    2. History of cerebrovascular accidents.
    3. History of advanced cardiac disease (heart failure, recent acute coronary syndrome, and cardiac arrhythmia).
    4. Active skin lesion
    5. large ultrafiltration volume per session(>2 Litter)
    6. Patients with dry skin.

-B-chronic kidney disease (CKD) group:-

  1. Diabetes mellitus .
  2. History of advanced heart failure, advanced liver cirrhosis, respiratory failure, and malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810989


Contacts
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Contact: yasser fysal, Master +201012872076 Y.fysal89@aun.edu.eg
Contact: Adel Mekawy, Ph.D. +201064347436 Adelmek69@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ashraf Elshazly, professor Assiut University
Publications of Results:
Other Publications:
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Responsible Party: Yasser Abd Elmawgood Fysal Ibrahim, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03810989    
Other Study ID Numbers: skin as third kidney
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasser Abd Elmawgood Fysal Ibrahim, Assiut University:
dermodialysis
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases