Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time

Dialysis; Complications Clinical Trial

Official title:

Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time: A Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05418647
• Other study ID #: dialysate Na and DRT
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: June 2023
• Source: Alexandria University
• Contact: Mohamed Mamdouh Elsayed, MD
• Phone: 00201068055103
• Email: dr_mohamedmamdouh87[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research aims to assess the effect of low versus high dialysate sodium concentration during hemodialysis on dialysis recovery time

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with end-stage renal disease who have been prescribed long term hemodialysis and undergo four-hour HD treatments three times a week for more than 90 days.

• Patient must be at least 18 years old. They must be able to read and write, as well as be in complete mental health.

Exclusion Criteria:

• Inability to complete the surveys due to reading or hearing difficulties, actual instability of clinical condition that necessitate hospitalization, dementia, active malignancy or liver failure.

Related Conditions & MeSH terms

• Dialysis; Complications

Intervention

Other:
• high dialysate Na
high dialysate sodium (Na = 141 mmol/L) for 8 weeks
• low dialysate Na
low dialysate sodium (Na = 136 mmol/L) for 8 weeks

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Aexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change in plasma sodium concentration	measuring plasma sodium concentration	baseline, weeks 4 and 8
Secondary	Change in the inter-dialytic weight gain	measuring the inter-dialytic weight gain	8 weeks
Secondary	Change in blood pressure (systolic, diastolic, mean)	measuring in blood pressure (systolic, diastolic, mean)	8 weeks
Secondary	Occurrence of intradialytic hypotension	incidence of intradialytic hypotension	8 weeks
Secondary	Occurrence of muscle cramps	incidence of muscle cramps	8 weeks
Secondary	Occurrence of headache	incidence of headache	8 weeks