<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810989</url>
  </required_header>
  <id_info>
    <org_study_id>skin as third kidney</org_study_id>
    <nct_id>NCT03810989</nct_id>
  </id_info>
  <brief_title>Dermodialysis as Adjuvant Therapy in Renal Failure</brief_title>
  <official_title>Using of the Skin as a Third Spare Kidney for Patients With Chronic Renal Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using sweat as the vehicle for removing molecules normally excreted in the&#xD;
      urine(dermodialysis) was identified some decades ago.The study will include 66 ESRD patients&#xD;
      and 20 CKD stage 5 patients not on dialysis who met inclusion and exclusion criteria. The&#xD;
      ESRD patients will be divided into three groups and will be subjected to different modalities&#xD;
      of stimulation of sweating like infra-red sauna , physical exercise and hot bath. The study&#xD;
      will be conducted over a period of three months. During the ﬁrst month, patients were&#xD;
      dialyzed as usual (control phase).During the next two months ,the participants will be&#xD;
      dialysed twice weekly in addition to dermodialysis. S Cr, BUN, serum K and serum phosphorus&#xD;
      will be measured weekly immediately before the last dialysis session during the control and&#xD;
      intervention phases. The mean of this investigations during each phase will be calculated .&#xD;
      The investigators will compare the mean of this investigations during control phase with the&#xD;
      mean during the intervention phase to evaluate the effectiveness of dermodialysis as adjuvant&#xD;
      therapy for ESRD patients.The patients not on dialysis will subjected to infra-red sauna and&#xD;
      hot bath.The investigators also will compare the means of S Cr, BUN, serum K and serum&#xD;
      phosphorus during both control and intervention phases like the ESRD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although dialysis has been considered as a life-saving treatment for end stage renal disease&#xD;
      (ESRD) patients, many ESRD patients in developing countries don't have access to dialysis&#xD;
      facilities . Using sweat as the vehicle for removing molecules normally excreted in the&#xD;
      urine(dermodialysis) was identified some decades ago. Sweat fluid mainly contains sodium&#xD;
      chloride, potassium, urea, ammonia, uric acid, and creatinine. The mean sweat fluid urea&#xD;
      concentration could reach 5.5 to 50 times the serum concentration . In particular, urea&#xD;
      concentrations in human sweat are persistently elevated in uremic patients . The 24-hour&#xD;
      urinary urea excretion in summer was as much as one-quarter of the quantity in winter in&#xD;
      uremic patients, indicating the compensatory urea excretion in sweat gland fluid .This high&#xD;
      level of urea and other toxic molecules crystallize out and deposit visibly on the skin when&#xD;
      the water of the sweat evaporates off ('uremic frost') .Sweat K concentration was&#xD;
      significantly higher in ESRD patients . Pruijm, El-Housseini et al reported that stimulated&#xD;
      sweating can be an effective way to reduce intradialytic weight gain(IDWG) in hemodialysis(&#xD;
      HD)patients. These findings indicated that dermodialysis can be used to delay the requirement&#xD;
      for and to reduce the frequency of dialysis and to improve the quality of lives of ESRD&#xD;
      patients especially in the developing World where economic and technical support barriers to&#xD;
      the provision of dialysis are present.&#xD;
&#xD;
      Sweating can be stimulated by many methods like physical exercise ,saunas and drugs like&#xD;
      pilocarpine. Traditional dry saunas use temperatures as high as 185 to 195 degrees F, which&#xD;
      is too much for some patients to tolerate. Infrared saunas use a much lower temperature (120&#xD;
      to 150 degrees F). However, because the heat of infrared saunas travels much deeper into the&#xD;
      body, they are able to cause a more vigorous sweat at lower temperature. Infrared sauna has&#xD;
      many benefits like normalizing blood pressure , treating congestive heart failure, weight&#xD;
      loss and relieving of chronic pain.&#xD;
&#xD;
      Head out water immersion was used many times in ESRD patients. Pruijm, El-Housseini et al&#xD;
      concluded that immersion in hot bath (temperature 37-43C) was effective method of stimulating&#xD;
      sweating and reducing IDWG. Intradialytic hypotension could be prevented by water immersion.&#xD;
&#xD;
      Primary objective:- Evaluation of feasibility of dermodialysis as adjuvant replacement&#xD;
      therapy for ESRD patients to decrease the cost of dialysis facilities (one third of the total&#xD;
      cost).&#xD;
&#xD;
      Secondary objectives:-&#xD;
&#xD;
        1. Improve uremic pruritus.&#xD;
&#xD;
        2. Better control of blood pressure.&#xD;
&#xD;
        3. Decrease interdialytic weight gain.&#xD;
&#xD;
        4. Comparing the effectiveness of infra-red sauna, exercise and combination of infra-red&#xD;
           sauna and head out water immersion as modality of dermodialysis The study will include&#xD;
           66 ESRD patients and 20 CKD stage 5 patients not on dialysis who met inclusion and&#xD;
           exclusion criteria. The ESRD patients will be subdivided into three group, each group&#xD;
           will include 22 patients .Each group will be subjected to Detailed history and Careful&#xD;
           examination. The study will be conducted over a period of three months(for each&#xD;
           patient). During the ﬁrst month, patients will be dialyzed as usual (control phase).&#xD;
           Detailed information on blood pressure, interdialytic weight gain (IDWG), and dialysis&#xD;
           prescription will be recorded. S Cr, BUN, serum K and serum phosphorus will be measured&#xD;
           weekly immediately before the last dialysis session for one month and the mean will be&#xD;
           calculated. During the next two months the patient will be dialysed twice weekly on&#xD;
           Saturday and Wednesday. during the in-between three days(Sunday, Monday and Tuesday) the&#xD;
           three groups subjected to intervention as the following :- Group 1:-three session of&#xD;
           infra-red sauna of 15 minutes duration separated by ten minutes rest outside the sauna.&#xD;
&#xD;
      Group 2:-three session of physical exercise of 20-30 minutes duration separated by 10 minutes&#xD;
      rest.&#xD;
&#xD;
      Group 3:-three session of infra-red sauna as the first group then the patients will be&#xD;
      immersed up to neck for one hour in water at 37-43 C.&#xD;
&#xD;
      Detailed information on IDWG, blood pressure, any improvement in uremic pruritus will be&#xD;
      recorded. Body temperature before and after the intervention will be measured and recorded.&#xD;
      Assessment of uremic pruritus according to verbal rating scale (VRS) which divided into four&#xD;
      level:-0=no symptom, 1=mild, 2= moderate, 3=sever or intense symptom. Dialysis prescription&#xD;
      and diet will be fixed as possible to be similar to the control phase.&#xD;
&#xD;
      S Cr, BUN, serum K and serum phosphorus will be measured weekly immediately before the last&#xD;
      dialysis session (Wednesday) for two months and the mean will be calculated. The patients&#xD;
      will be admitted in internal medicine department in the dialysis free period to be under&#xD;
      close observation. Dialysis will be done if there is urgent indication in the dialysis free&#xD;
      days.&#xD;
&#xD;
      The CKD group :- The patients will be subjected to Detailed history and Careful examination.&#xD;
      The study will be conducted over a period of three months. During the ﬁrst month (control&#xD;
      phase), S Cr, BUN, serum K and serum phosphorus will be measured weekly and the mean will be&#xD;
      calculated. During the next two months the patient will be subjected to three session of&#xD;
      sauna of 15 minutes duration separated by ten minutes rest outside the sauna then the&#xD;
      patients will be immersed up to neck for one hour in water at 37 -43 C . Body temperature&#xD;
      before and after the intervention will be measured and recorded. During the intervention&#xD;
      phase, S Cr, BUN, serum K and serum phosphorus will be measured weekly and the mean will be&#xD;
      calculated. During the period of rest the patients will consume sufficient amount of water to&#xD;
      avoid dehydration .Blood pressure will be monitored and recorded. Dialysis will be done if&#xD;
      there is urgent indication or standard indication for dialysis according to KDOQI guide lines&#xD;
      2015.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>the same groups of patients will be used for the experimental and control groups (self controlled study or time series study).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in the mean of BUN, serum Cr, serum k and serum phosphorus .</measure>
    <time_frame>3months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in interdialytic weight gain(IDWG)</measure>
    <time_frame>3months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect on uremic pruritus</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Chronic Renal Failure</condition>
  <arm_group>
    <arm_group_label>infra-red sauna</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>argometer and treadmill</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combination of sauna and hot bath</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combination of sauna and hot bath in CKD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>infra-red sauna</intervention_name>
    <description>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.</description>
    <arm_group_label>infra-red sauna</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>argometer and treadmill</intervention_name>
    <description>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.</description>
    <arm_group_label>argometer and treadmill</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>combination of sauna and hot bath</intervention_name>
    <description>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.</description>
    <arm_group_label>combination of sauna and hot bath</arm_group_label>
    <arm_group_label>combination of sauna and hot bath in CKD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A-chronic renal failure groups:-&#xD;
&#xD;
               1. Patients with chronic renal failure on regular haemodialysis three times a week.&#xD;
&#xD;
               2. starting regular haemodialysis at least 6 months before the beginning of the&#xD;
                  study.&#xD;
&#xD;
               3. Ability to perform physical exercise in argometer and treadmill arm.&#xD;
&#xD;
          -  B-chronic kidney disease(CKD) group:&#xD;
&#xD;
               -  1- CKD stage 5 (eGFR 10-15ml /min calculated by EPI equation).&#xD;
&#xD;
                  2-Not on dialysis.&#xD;
&#xD;
                  3-Without uremic symptoms nor standard indication for dialysis according to KDOQI&#xD;
                  guide lines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A-ESRD groups:-&#xD;
&#xD;
               1. Having temporary or tunneled catheter as modality of vascular access.&#xD;
&#xD;
               2. History of cerebrovascular accidents.&#xD;
&#xD;
               3. History of advanced cardiac disease (heart failure, recent acute coronary&#xD;
                  syndrome, and cardiac arrhythmia).&#xD;
&#xD;
               4. Active skin lesion&#xD;
&#xD;
               5. large ultrafiltration volume per session(&gt;2 Litter)&#xD;
&#xD;
               6. Patients with dry skin.&#xD;
&#xD;
        -B-chronic kidney disease (CKD) group:-&#xD;
&#xD;
          1. Diabetes mellitus .&#xD;
&#xD;
          2. History of advanced heart failure, advanced liver cirrhosis, respiratory failure, and&#xD;
             malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashraf Elshazly, professor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>yasser fysal, Master</last_name>
    <phone>+201012872076</phone>
    <email>Y.fysal89@aun.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adel Mekawy, Ph.D.</last_name>
    <phone>+201064347436</phone>
    <email>Adelmek69@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>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.</citation>
    <PMID>7798794</PMID>
  </reference>
  <reference>
    <citation>Mohan D, Railey M. Uremic frost. Kidney Int. 2012 Jun;81(11):1153. doi: 10.1038/ki.2012.70. No abstract available.</citation>
    <PMID>22584601</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12817713</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9373914</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16525136</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16316385</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17063176</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>5960700</PMID>
  </results_reference>
  <results_reference>
    <citation>Lacher JW, Schrier RW. Sweating treatment for chronic renal failure. Nephron. 1978;21(5):255-9. doi: 10.1159/000181401.</citation>
    <PMID>714199</PMID>
  </results_reference>
  <results_reference>
    <citation>Vance DJ. Dermodialysis-Could sweating treatments for chronic renal failure substantially and feasibly improve outcomes in developing and even developed world contexts?</citation>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>23013432</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>29436152</PMID>
  </results_reference>
  <results_reference>
    <citation>Beever R. Far-infrared saunas for treatment of cardiovascular risk factors: summary of published evidence. Can Fam Physician. 2009 Jul;55(7):691-6.</citation>
    <PMID>19602651</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Yasser Abd Elmawgood Fysal Ibrahim</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>dermodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810989
org study id: skin as third kidney
nct id: NCT03810989
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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).
primary purpose: Treatment
masking: None (Open Label)
measure: change in the mean of BUN, serum Cr, serum k and serum phosphorus .
time frame: 3months
description: 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.
measure: change in interdialytic weight gain(IDWG)
time frame: 3months
description: 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.
measure: The effect on uremic pruritus
time frame: 3 months
description: 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.
arm group label: infra-red sauna
arm group type: Experimental
description: 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.
arm group label: argometer and treadmill
arm group type: Experimental
description: 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.
arm group label: combination of sauna and hot bath
arm group type: Experimental
description: 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.
arm group label: combination of sauna and hot bath in CKD
arm group type: Experimental
description: 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 .
intervention type: Device
intervention name: infra-red sauna
description: 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.
arm group label: infra-red sauna
intervention type: Device
intervention name: argometer and treadmill
description: 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.
arm group label: argometer and treadmill
intervention type: Device
intervention name: combination of sauna and hot bath
description: 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.
arm group label: combination of sauna and hot bath
arm group label: combination of sauna and hot bath in CKD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ashraf Elshazly, professor
role: Study Director
affiliation: Assiut University
last name: yasser fysal, Master
phone: +201012872076
email: Y.fysal89@aun.edu.eg
last name: Adel Mekawy, Ph.D.
phone: +201064347436
email: Adelmek69@yahoo.com
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PMID: 17063176
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PMID: 714199
citation: Vance DJ. Dermodialysis-Could sweating treatments for chronic renal failure substantially and feasibly improve outcomes in developing and even developed world contexts?
citation: 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.
PMID: 23013432
citation: 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.
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PMID: 19602651
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Yasser Abd Elmawgood Fysal Ibrahim
investigator title: assistant lecturer
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided