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NCT Number: NCT05418647

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Aexandria University, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high dialysate Na

Other

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

low dialysate Na

Other

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

Primary outcomes

  1. Change in dialysis recovery time

    Time frame: baseline, weeks 4 and 8

    By assessing the patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?"

Secondary outcomes

  1. Change in plasma sodium concentration

    Time frame: baseline, weeks 4 and 8

    measuring plasma sodium concentration

  2. Change in the inter-dialytic weight gain

    Time frame: 8 weeks

    measuring the inter-dialytic weight gain

  3. Change in blood pressure (systolic, diastolic, mean)

    Time frame: 8 weeks

    measuring in blood pressure (systolic, diastolic, mean)

  4. Occurrence of intradialytic hypotension

    Time frame: 8 weeks

    incidence of intradialytic hypotension

  5. Occurrence of muscle cramps

    Time frame: 8 weeks

    incidence of muscle cramps

  6. Occurrence of headache

    Time frame: 8 weeks

    incidence of headache

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Mamdouh Elsayed, MD

CONTACT

[email protected]

00201068055103

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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