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Chronic Renal FailureNCT03810989

Dermodialysis as Adjuvant Therapy in Renal Failure

A study testing infra-red sauna, argometer and treadmill and combination of sauna and hot bath in people with Chronic Renal Failure, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Renal Failure
What is being tested?
infra-red sauna, argometer and treadmill and combination of sauna and hot bath
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
No sites listed yet
Study dates
1 Jun 2019to 1 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A-chronic renal failure groups:-
  • Patients with chronic renal failure on regular haemodialysis three times a week.
  • starting regular haemodialysis at least 6 months before the beginning of the study.
  • 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.

Who cannot join

  • A-ESRD groups:-
  • Having temporary or tunneled catheter as modality of vascular access.
  • History of cerebrovascular accidents.
  • History of advanced cardiac disease (heart failure, recent acute coronary syndrome, and cardiac arrhythmia).
  • Active skin lesion
  • large ultrafiltration volume per session(>2 Litter)
Show all 10Show fewer
  • Patients with dry skin.
  • -B-chronic kidney disease (CKD) group:-
  • Diabetes mellitus .
  • History of advanced heart failure, advanced liver cirrhosis, respiratory failure, and malignancy

Trial locations and contacts

No sites are listed yet.

yasser fysal, Master contact

+201012872076

Y.fysal89@aun.edu.eg

Adel Mekawy, Ph.D. contact

+201064347436

Adelmek69@yahoo.com

About this study

Official title: Using of the Skin as a Third Spare Kidney for Patients With Chronic Renal Failure

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.

Read the detailed description

Although dialysis has been considered as a life-saving treatment for end stage renal disease (ESRD) patients, many ESRD patients in developing countries don't have access to dialysis facilities . Using sweat as the vehicle for removing molecules normally excreted in the urine(dermodialysis) was identified some decades ago. Sweat fluid mainly contains sodium chloride, potassium, urea, ammonia, uric acid, and creatinine. The mean sweat fluid urea concentration could reach 5.5 to 50 times the serum concentration . In particular, urea concentrations in human sweat are persistently elevated in uremic patients . The 24-hour urinary urea excretion in summer was as much as one-quarter of the quantity in winter in uremic patients, indicating the compensatory urea excretion in sweat gland fluid .This high level of urea and other toxic molecules crystallize out and deposit visibly on the skin when the water of the sweat evaporates off ('uremic frost') .Sweat K concentration was significantly higher in ESRD patients . Pruijm, El-Housseini et al reported that stimulated sweating can be an effective way to reduce intradialytic weight gain(IDWG) in hemodialysis( HD)patients. These findings indicated that dermodialysis can be used to delay the requirement for and to reduce the frequency of dialysis and to improve the quality of lives of ESRD patients especially in the developing World where economic and technical support barriers to the provision of dialysis are present.

Sweating can be stimulated by many methods like physical exercise ,saunas and drugs like pilocarpine. Traditional dry saunas use temperatures as high as 185 to 195 degrees F, which is too much for some patients to tolerate. Infrared saunas use a much lower temperature (120 to 150 degrees F). However, because the heat of infrared saunas travels much deeper into the body, they are able to cause a more vigorous sweat at lower temperature. Infrared sauna has many benefits like normalizing blood pressure , treating congestive heart failure, weight loss and relieving of chronic pain.

Head out water immersion was used many times in ESRD patients. Pruijm, El-Housseini et al concluded that immersion in hot bath (temperature 37-43C) was effective method of stimulating sweating and reducing IDWG. Intradialytic hypotension could be prevented by water immersion.

Primary objective:- Evaluation of feasibility of dermodialysis as adjuvant replacement therapy for ESRD patients to decrease the cost of dialysis facilities (one third of the total cost).

Secondary objectives:-

  1. Improve uremic pruritus.
  2. Better control of blood pressure.
  3. Decrease interdialytic weight gain.
  4. Comparing the effectiveness of infra-red sauna, exercise and combination of infra-red sauna and head out water immersion as modality of dermodialysis 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 subdivided into three group, each group will include 22 patients .Each group will be subjected to Detailed history and Careful examination. The study will be conducted over a period of three months(for each patient). During the first month, patients will be dialyzed as usual (control phase). Detailed information on blood pressure, interdialytic weight gain (IDWG), and dialysis prescription will be recorded. S Cr, BUN, serum K and serum phosphorus will be measured weekly immediately before the last dialysis session for one month and the mean will be calculated. During the next two months the patient will be dialysed twice weekly on Saturday and Wednesday. during the in-between three days(Sunday, Monday and Tuesday) the three groups subjected to intervention as the following :- Group 1:-three session of infra-red sauna of 15 minutes duration separated by ten minutes rest outside the sauna.

Group 2:-three session of physical exercise of 20-30 minutes duration separated by 10 minutes rest.

Group 3:-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.

Detailed information on IDWG, blood pressure, any improvement in uremic pruritus will be recorded. Body temperature before and after the intervention will be measured and recorded. Assessment of uremic pruritus according to verbal rating scale (VRS) which divided into four level:-0=no symptom, 1=mild, 2= moderate, 3=sever or intense symptom. Dialysis prescription and diet will be fixed as possible to be similar to the control phase.

S Cr, BUN, serum K and serum phosphorus will be measured weekly immediately before the last dialysis session (Wednesday) for two months and the mean will be calculated. The patients will be admitted in internal medicine department in the dialysis free period to be under close observation. Dialysis will be done if there is urgent indication in the dialysis free days.

The CKD group :- The patients will be subjected to Detailed history and Careful examination. The study will be conducted over a period of three months. 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 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 . Body temperature before and after the intervention will be measured and recorded. During the intervention phase, S Cr, BUN, serum K and serum phosphorus will be measured weekly and the mean will be calculated. During the period of rest the patients will consume sufficient amount of water to avoid dehydration .Blood pressure will be monitored and recorded. Dialysis will be done if there is urgent indication or standard indication for dialysis according to KDOQI guide lines 2015.

Being tested
infra-red sauna, argometer and treadmill, combination of sauna and hot bath
Keywords
dermodialysis
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infra-red saunaDevice

    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.

  • argometer and treadmillDevice

    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.

  • combination of sauna and hot bathDevice

    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.

Study groups in NCT03810989
Study groupRoleWhat they receive
infra-red saunaExperimentalDuring 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.
Receives: Device: infra-red sauna
argometer and treadmillExperimentalDuring 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.
Receives: Device: argometer and treadmill
combination of sauna and hot bathExperimentalDuring 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.
Receives: Device: combination of sauna and hot bath
combination of sauna and hot bath in CKDExperimentalDuring 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 .
Receives: Device: combination of sauna and hot bath

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in the mean of BUN, serum Cr, serum k and serum phosphorus .

    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.

    Measured: 3months

  2. change in interdialytic weight gain(IDWG)

    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.

    Measured: 3months

Secondary outcomes (1)
  1. The effect on uremic pruritus

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start1 Jun 2019 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion1 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03810989
Sponsor's protocol ID
skin as third kidney
Status last verified
Jan 2019
First submitted
17 Jan 2019
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yosipovitch G, Reis J, Tur E, Blau H, Harell D, Morduchowicz G, Boner G. Sweat electrolytes in patients with advanced renal failure. J Lab Clin Med. 1994 Dec;124(6):808-12.

    PubMed 7798794
  • Mohan D, Railey M. Uremic frost. Kidney Int. 2012 Jun;81(11):1153. doi: 10.1038/ki.2012.70. No abstract available.

    PubMed 22584601
  • 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.

    PubMed 12817713
  • 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.

    PubMed 9373914
  • Barsoum RS. Chronic kidney disease in the developing world. N Engl J Med. 2006 Mar 9;354(10):997-9. doi: 10.1056/NEJMp058318. No abstract available.

    PubMed 16525136
  • El Nahas M. The global challenge of chronic kidney disease. Kidney Int. 2005 Dec;68(6):2918-29. doi: 10.1111/j.1523-1755.2005.00774.x. No abstract available.

    PubMed 16316385
  • Modi GK, Jha V. The incidence of end-stage renal disease in India: a population-based study. Kidney Int. 2006 Dec;70(12):2131-3. doi: 10.1038/sj.ki.5001958. Epub 2006 Oct 25.

    PubMed 17063176
  • Snyder D, Merrill JP. Sauna baths in the treatment of chronic renal failure. Trans Am Soc Artif Intern Organs. 1966;12:188-92. No abstract available.

    PubMed 5960700
  • Lacher JW, Schrier RW. Sweating treatment for chronic renal failure. Nephron. 1978;21(5):255-9. doi: 10.1159/000181401.

    PubMed 714199
  • Vance DJ. Dermodialysis-Could sweating treatments for chronic renal failure substantially and feasibly improve outcomes in developing and even developed world contexts?

  • Pruijm M, El-Housseini Y, Mahfoudh H, Jarraya F, Hachicha J, Teta D, Burnier M. Stimulated sweating as a therapy to reduce interdialytic weight gain and improve potassium balance in chronic hemodialysis patients: a pilot study. Hemodial Int. 2013 Apr;17(2):240-8. doi: 10.1111/j.1542-4758.2012.00751.x. Epub 2012 Sep 26.

    PubMed 23013432
  • Doenyas-Barak K, Garra N, Beberashvili I, Efrati S. Immersion-enhanced fluid redistribution can prevent intradialytic hypotension: A prospective, randomized, crossover clinical trial. Hemodial Int. 2018 Jul;22(3):377-382. doi: 10.1111/hdi.12634. Epub 2018 Feb 13.

    PubMed 29436152
  • Beever R. Far-infrared saunas for treatment of cardiovascular risk factors: summary of published evidence. Can Fam Physician. 2009 Jul;55(7):691-6.

    PubMed 19602651

Questions about this trial

What is this clinical trial studying?

A study testing infra-red sauna, argometer and treadmill and combination of sauna and hot bath in people with Chronic Renal Failure, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yasser fysal, Master (+201012872076, Y.fysal89@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in the mean of BUN, serum Cr, serum k and serum phosphorus . (time frame: 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03810989, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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