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

June 11, 2023 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Faculty of Medicine, Aexandria University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high dialysate Na
They will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks.
Other: high dialysate Na
high dialysate sodium (Na = 141 mmol/L) for 8 weeks
Experimental: low dialysate Na
They will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks.
Other: low dialysate Na
low dialysate sodium (Na = 136 mmol/L) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
baseline, weeks 4 and 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: osama M Refai, MBBCh, resident of Nephrology & Internal Medicine, Alexandria University Hospitals
  • Principal Investigator: Mohamed Mamdouh Elsayed, MD, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2023

Primary Completion (Estimated)

September 15, 2023

Study Completion (Estimated)

October 15, 2023

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dialysate Na and DRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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