Dermodialysis as Adjuvant Therapy in Renal Failure

NCT03810989 | Unknown

• 1 other identifier: skin as third kidney
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Renal Failure

Keywords

dermodialysis

Outcome Measures

Primary Outcomes (2)

• 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.

  3months

• 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.

  3months

Secondary Outcomes (1)

• The effect on uremic pruritus

  3 months

Study Arms (4)

infra-red sauna

EXPERIMENTAL

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

argometer and treadmill

EXPERIMENTAL

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

combination of sauna and hot bath

EXPERIMENTAL

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

combination of sauna and hot bath in CKD

EXPERIMENTAL

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

Interventions

infra-red sauna DEVICE

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.

infra-red sauna

argometer and treadmill DEVICE

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.

argometer and treadmill

combination of sauna and hot bath DEVICE

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.

combination of sauna and hot bath; combination of sauna and hot bath in CKD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• CKD stage 5 (eGFR 10-15ml /min calculated by EPI equation).
• Not on dialysis.
• Without uremic symptoms nor standard indication for dialysis according to KDOQI guide lines.

You may not qualify if:

• 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)
• Patients with dry skin.
• B-chronic kidney disease (CKD) group:-
• Diabetes mellitus .
• History of advanced heart failure, advanced liver cirrhosis, respiratory failure, and malignancy

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• 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.

  PMID: 7798794 BACKGROUND

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

  PMID: 22584601 BACKGROUND

• 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: 12817713 BACKGROUND

• 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: 9373914 BACKGROUND

• 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.

  PMID: 16525136 BACKGROUND

• 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.

  PMID: 16316385 BACKGROUND

• 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.

  PMID: 17063176 BACKGROUND

• 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.

  PMID: 5960700 RESULT

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

  PMID: 714199 RESULT

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

  RESULT

• 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 RESULT

• 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.

  PMID: 29436152 RESULT

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

  PMID: 19602651 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashraf Elshazly, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

yasser fysal, Master

CONTACT

+201012872076; Y.fysal89@aun.edu.eg

Adel Mekawy, Ph.D.

CONTACT

+201064347436; Adelmek69@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: the same groups of patients will be used for the experimental and control groups (self controlled study or time series study).

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 23, 2019

Record last verified: 2019-01