Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research aims to assess the effect of low versus high dialysate sodium concentration during hemodialysis on dialysis recovery time
Chronic kidney disease (CKD) is a general term for heterogeneous disorders affecting the structure and function of the kidney. The variation in disease expression is partly related to the cause, pathology, severity and the rate of progression. Fatigue is a well-known and frequent symptom in HD patients with a reported association with the decrease in health-related quality of life commonly found in this population. The prevalence of fatigue ranges from 60% to as high as 97% in patients on long-term renal replacement therapy. Despite this fact, health care providers are still unaware of both its presence and severity. Several methods have been proposed as a way to assess post-HD fatigue with the "time to recover (minutes) from HD" being one of them. Lindsay et al.assisted patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?". Although post-HD fatigue commonly exists in dialysis patients, it is usually underestimated by physicians. For this reason, appropriate and early identification of symptoms and associated factors might improve the patient's quality of life. Rayner et al. found that dialysate Na was inversely associated with DRT where lowering the Na concentration in the dialysate (to 140 mEq/L) was linked to a longer DRT.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dialysate Na | Experimental | They will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks. |
|
| low dialysate Na | Experimental | They will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high dialysate Na | Other | high dialysate sodium (Na = 141 mmol/L) for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dialysis recovery time | By assessing the patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?" | baseline, weeks 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma sodium concentration | measuring plasma sodium concentration | baseline, weeks 4 and 8 |
| Change in the inter-dialytic weight gain | measuring the inter-dialytic weight gain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Mamdouh Elsayed, MD | Contact | 00201068055103 | dr_mohamedmamdouh87@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Mamdouh Elsayed, MD | lecturer | Principal Investigator |
| osama M Refai, MBBCh | resident of Nephrology & Internal Medicine, Alexandria University Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Aexandria University | Not yet recruiting | Alexandria | 21526 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19231760 | Background | Levey AS, Stevens LA, Coresh J. Conceptual model of CKD: applications and implications. Am J Kidney Dis. 2009 Mar;53(3 Suppl 3):S4-16. doi: 10.1053/j.ajkd.2008.07.048. | |
| 17200048 | Background | Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001. |
Not provided
Not provided
Not provided
This research is a single-blinded randomized clinical trial in which 40 haemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
Not provided
Not provided
a single blinded study as participants will be unaware about the dialysate Na each patient receives
| low dialysate Na |
| Other |
low dialysate sodium (Na = 136 mmol/L) for 8 weeks |
|
| 8 weeks |
| Change in blood pressure (systolic, diastolic, mean) | measuring in blood pressure (systolic, diastolic, mean) | 8 weeks |
| Occurrence of intradialytic hypotension | incidence of intradialytic hypotension | 8 weeks |
| Occurrence of muscle cramps | incidence of muscle cramps | 8 weeks |
| Occurrence of headache | incidence of headache | 8 weeks |
| Faculty of Medicine, Alexandria University | Recruiting | Alexandria | Egypt |
|
| 15975996 | Background | Weisbord SD, Fried LF, Arnold RM, Fine MJ, Levenson DJ, Peterson RA, Switzer GE. Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol. 2005 Aug;16(8):2487-94. doi: 10.1681/ASN.2005020157. Epub 2005 Jun 23. |
| 17702730 | Background | Weisbord SD, Fried LF, Mor MK, Resnick AL, Unruh ML, Palevsky PM, Levenson DJ, Cooksey SH, Fine MJ, Kimmel PL, Arnold RM. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2007 Sep;2(5):960-7. doi: 10.2215/CJN.00990207. Epub 2007 Aug 8. |
| 17699312 | Background | Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R; Daily Hemodialysis Study Group London Health Sciences Centre. Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. Clin J Am Soc Nephrol. 2006 Sep;1(5):952-9. doi: 10.2215/CJN.00040106. Epub 2006 Jul 6. |
| 24529994 | Background | Rayner HC, Zepel L, Fuller DS, Morgenstern H, Karaboyas A, Culleton BF, Mapes DL, Lopes AA, Gillespie BW, Hasegawa T, Saran R, Tentori F, Hecking M, Pisoni RL, Robinson BM. Recovery time, quality of life, and mortality in hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2014 Jul;64(1):86-94. doi: 10.1053/j.ajkd.2014.01.014. Epub 2014 Feb 14. |