Dialysis; ComplicationsNCT05418647
Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time
A study testing high dialysate Na and low dialysate Na in people with Dialysis; Complications, run by Alexandria University at 2 sites in Egypt.
Trial summary
This research aims to assess the effect of low versus high dialysate sodium concentration during hemodialysis on dialysis recovery time Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- high dialysate Na and low dialysate Na
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Apr 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Faculty of Medicine, Aexandria University
Alexandria, 21526
Mohamed mamdouh Elsayed, MD, 00201068055103, dr_mohamedmamdouh87@yahoo.com
- Recruiting
Faculty of Medicine, Alexandria University
Alexandria
mohamed mamdouh elsayed, MD, dr_mohamedmamdouh87@yahoo.com
About this study
Official title: 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
Read the 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.
- Conditions
- Dialysis; Complications
- Being tested
- high dialysate Na, low dialysate Na
- Keywords
- hemodialysis, recovery time, dialysate Na
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dialysate NaOther
high dialysate sodium (Na = 141 mmol/L) for 8 weeks
low dialysate NaOther
low dialysate sodium (Na = 136 mmol/L) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| high dialysate Na | Experimental | They will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks. Receives: Other: high dialysate Na |
| low dialysate Na | Experimental | They will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks. Receives: Other: low dialysate Na |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: baseline, weeks 4 and 8
Secondary outcomes (6)
Change in plasma sodium concentration
measuring plasma sodium concentration
Measured: baseline, weeks 4 and 8
Change in the inter-dialytic weight gain
measuring the inter-dialytic weight gain
Measured: 8 weeks
Change in blood pressure (systolic, diastolic, mean)
measuring in blood pressure (systolic, diastolic, mean)
Measured: 8 weeks
Occurrence of intradialytic hypotension
incidence of intradialytic hypotension
Measured: 8 weeks
Occurrence of muscle cramps
incidence of muscle cramps
Measured: 8 weeks
Occurrence of headache
incidence of headache
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start15 Apr 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed Mamdouh Elsayed, MD, Principal investigator, lecturerosama M Refai, MBBCh, Study chair, resident of Nephrology & Internal Medicine, Alexandria University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418647
- Sponsor's protocol ID
- dialysate Na and DRT
- Status last verified
- Feb 2025
- First submitted
- 10 Jun 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19231760Murtagh 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.
PubMed 17200048Weisbord 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.
PubMed 15975996Weisbord 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.
PubMed 17702730Lindsay 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.
PubMed 17699312Rayner 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.
PubMed 24529994
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05418647
- Acronym / sponsor ID
- dialysate Na and DRT
- Conditions
- Dialysis; Complications
- Keywords
- hemodialysis, recovery time, dialysate Na
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to assess the effect of low versus high dialysate sodium concentration during hemodialysis on dialysis recovery time
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| high dialysate Na | Experimental | Other: high dialysate NaThey will receive high dialysate sodium (Na = 141 mmol/L) for 8 weeks. |
| low dialysate Na | Experimental | Other: low dialysate NaThey will receive low dialysate sodium (Na = 136 mmol/L) for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dialysate Nahigh dialysate sodium (Na = 141 mmol/L) for 8 weeks | Other | high dialysate Na |
| low dialysate Nalow dialysate sodium (Na = 136 mmol/L) for 8 weeks | Other | low dialysate Na |
Primary outcome
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?"
6 secondary outcomes
Change in plasma sodium concentration
Time frame: baseline, weeks 4 and 8
Change in the inter-dialytic weight gain
Time frame: 8 weeks
Change in blood pressure (systolic, diastolic, mean)
Time frame: 8 weeks
Occurrence of intradialytic hypotension
Time frame: 8 weeks
Occurrence of muscle cramps
Time frame: 8 weeks
Occurrence of headache
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 19231760Levey 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.
- Background: PubMed 17200048Murtagh 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.
- Background: PubMed 15975996Weisbord 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.
- Background: PubMed 17702730Weisbord 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.
- Background: PubMed 17699312Lindsay 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.
- Background: PubMed 24529994Rayner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Mamdouh Elsayed, MD principal investigator
lecturer
osama M Refai, MBBCh study chair
resident of Nephrology & Internal Medicine, Alexandria University Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high dialysate Na and low dialysate Na in people with Dialysis; Complications, run by Alexandria University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mamdouh Elsayed, MD (00201068055103, dr_mohamedmamdouh87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dialysis recovery time (time frame: baseline, weeks 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05418647, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.