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

NCT05418647 | Recruiting

• 1 other identifier: dialysate Na and DRT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Dialysis; Complications

Keywords

hemodialysis, recovery time, dialysate Na

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in plasma sodium concentration

  baseline, weeks 4 and 8

• Change in the inter-dialytic weight gain

  8 weeks

• Change in blood pressure (systolic, diastolic, mean)

  8 weeks

• Occurrence of intradialytic hypotension

  8 weeks

• Occurrence of muscle cramps

  8 weeks

Study Arms (2)

high dialysate Na

EXPERIMENTAL

They will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks.

Other: high dialysate Na

low dialysate Na

EXPERIMENTAL

They will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks.

Other: low dialysate Na

Interventions

high dialysate Na OTHER

high dialysate sodium (Na = 141 mmol/L) for 8 weeks

high dialysate Na

low dialysate Na OTHER

low dialysate sodium (Na = 136 mmol/L) for 8 weeks

low dialysate Na

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

NOT YET RECRUITING

Faculty of Medicine, Alexandria University

Alexandria, Egypt

RECRUITING

Related 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.

  PMID: 19231760 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.

  PMID: 17200048 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.

  PMID: 15975996 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.

  PMID: 17702730 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.

  PMID: 17699312 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.

  PMID: 24529994 BACKGROUND

Study Officials

• Mohamed Mamdouh Elsayed, MD

  lecturer

  PRINCIPAL INVESTIGATOR

• osama M Refai, MBBCh

  resident of Nephrology & Internal Medicine, Alexandria University Hospitals

  STUDY CHAIR

Central Study Contacts

Mohamed Mamdouh Elsayed, MD

CONTACT

00201068055103; dr_mohamedmamdouh87@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: a single blinded study as participants will be unaware about the dialysate Na each patient receives
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor & lecturer

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 14, 2022
• Study Start: April 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

EG (2)