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

NCT ID: NCT05418647

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2025-08-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Dialysis; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
a single blinded study as participants will be unaware about the dialysate Na each patient receives

Study Groups

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high dialysate Na

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

Group Type EXPERIMENTAL

high dialysate Na

Intervention Type OTHER

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

low dialysate Na

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

Group Type EXPERIMENTAL

low dialysate Na

Intervention Type OTHER

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

Interventions

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high dialysate Na

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

Intervention Type OTHER

low dialysate Na

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Assistant professor & lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Mamdouh Elsayed, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer

osama M Refai, MBBCh

Role: STUDY_CHAIR

resident of Nephrology & Internal Medicine, Alexandria University Hospitals

Locations

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Faculty of Medicine, Aexandria University

Alexandria, , Egypt

Site Status NOT_YET_RECRUITING

Faculty of Medicine, Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Mamdouh Elsayed, MD

Role: CONTACT

00201068055103

Facility Contacts

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Mohamed mamdouh Elsayed, MD

Role: primary

00201068055103

mohamed mamdouh elsayed, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19231760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17200048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15975996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17702730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17699312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24529994 (View on PubMed)

Other Identifiers

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dialysate Na and DRT

Identifier Type: -

Identifier Source: org_study_id

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