Dialysis Related ComplicationNCT06962124
How to Prevent Complications During Dialysis
A study testing serum sodium measurment in people with Dialysis Related Complication, run by Assiut University.
Trial summary
We aimed to determine the effect of accurate assessment of dry weight based on measuring blood sodium level before dialysis to evaluate the effect of adjustment of ultrafiltration rate on hemodialysis complications and take a step forward to improve patient care and the quality of hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dialysis Related Complication
- What is being tested?
- serum sodium measurment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6- not dependent to mechanical ventilation
- at least one year history of hemodialysis
- adults aged 18 to 65 years old
- ability to communicate verbally
- with no history of diabetes mellitus, urinary incontinence syndrome, heart and liver failure, and adrenal hypertrophy 5 -no use of antihypertensive and antispasmodic drugs four hours before dialysis
Who cannot join
- 1- Impaired consciousness 2- participant's withdrawal from the study 5-death 3- severe blood supply problem in the fistula or vascular access 4-migration or travel during the study
- -
About this study
Official title: The Effect of Accurate Measurement of Dry Weight Based on pre_dialysis Serum Sodium Measurement on Reduction of Hemodialysis Complications
We aimed to determine the effect of accurate assessment of dry weight based on measuring blood sodium level before dialysis to evaluate the effect of adjustment of ultrafiltration rate on hemodialysis complications and take a step forward to improve patient care and the quality of hemodialysis.
Read the detailed description
Dialysis has become an integral part of daily routine for kidney failure patients. so, if we can reduce complications during sessions, we will reduce the burden of life as a whole ¬. Haemodialysis problems are frequent (1).
The definitions of dry weight have changed over time but can be defined as the lowest post-dialysis weight tolerated without significant signs of hypovolaemia.(2) It should be mentioned that the incidence of complications during hemodialysate depends on the balance between the rate of ultrafiltration and changes in plasma volume. The amount of ultrafiltration is typically determined by calculating the patient's dry weight.(3) Common problems during haemodialysis, in order of frequency, are: hypotension of around 23%, muscle cramps of roughly 10 to 20%, and nausea and vomiting of 10%. (4, 5). About 60 to 90% of dialysis patients suffer fatigue, which is one of the most prevalent complaints in people receiving hemodialysis.(6) aggressive ultrafiltration and targeting an inappropriately low dry weight can lead to intradialytic hypotension (IDH), nausea, central nervous system dysfunction, cramping, and risks compromising vascular access and worsening residual renal function.(7) Determining the patients' accurate dry weight is essential to minimizing these issues. When dry weight is accurately determined, quick variations in blood volume are avoided, which lowers the risk of problems during haemodialysis(8). The measurement of arterial natriuretic peptide (half-life of approximately 2 to 4 minutes), cyclic guanidine monophosphate, the diameter of the inferior vena cava (by echocardiography), bioimpedance (based on resistance measurement), and blood volume (by tracking changes in serum protein and hemoglobin) are used to determine dry weight.(9, 10) These techniques frequently need specialized equipment and are expensive. However, one practical way to measure dry weight prior to dialysis is to measure the amount of sodium, the most prevalent cation in extracellular fluid .(11)
- Conditions
- Dialysis Related Complication
- Being tested
- serum sodium measurment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum sodium measurmentOther
serum sodium measurment
| Study group | Role | What they receive |
|---|---|---|
| Effect of measurement of dry weight based on pre dialysis serum sodium measurment on reduction of h | Experimental | measurement of dry weight based on pre dialysis serum sodium Receives: Other: serum sodium measurment |
What is being measured
The primary outcome is the main question the study is designed to answer.
predict correlation between accurate measurement of dry weight in kilogram by predialytic serum sodium level and incidence of complications.
We aimed to determine the effect of assessment of dry weight based on measuring blood sodium level before dialysis to evaluate the effect of adjustment of ultrafilteration rate on haemodialysis complications and take a step forward to improve patient care and the quality of hemodialysis
Measured: 3 month ( 39 session for each patient , 13 session per month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Related ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Raafat Helmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962124
- Sponsor's protocol ID
- complications during dialysis
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Accurate Measurement of Dry Weight Based on pre_dialysis Serum Sodium Measurement on Reduction of Hemodialysis Complications
- ClinicalTrials.gov ID
- NCT06962124
- Acronym / sponsor ID
- complications during dialysis
- Conditions
- Dialysis Related Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 May 2025 (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.
We aimed to determine the effect of accurate assessment of dry weight based on measuring blood sodium level before dialysis to evaluate the effect of adjustment of ultrafiltration rate on hemodialysis complications and take a step forward to improve patient care and the quality of hemodialysis.
Detailed description
Dialysis has become an integral part of daily routine for kidney failure patients. so, if we can reduce complications during sessions, we will reduce the burden of life as a whole ¬. Haemodialysis problems are frequent (1).
The definitions of dry weight have changed over time but can be defined as the lowest post-dialysis weight tolerated without significant signs of hypovolaemia.(2) It should be mentioned that the incidence of complications during hemodialysate depends on the balance between the rate of ultrafiltration and changes in plasma volume. The amount of ultrafiltration is typically determined by calculating the patient's dry weight.(3) Common problems during haemodialysis, in order of frequency, are: hypotension of around 23%, muscle cramps of roughly 10 to 20%, and nausea and vomiting of 10%. (4, 5). About 60 to 90% of dialysis patients suffer fatigue, which is one of the most prevalent complaints in people receiving hemodialysis.(6) aggressive ultrafiltration and targeting an inappropriately low dry weight can lead to intradialytic hypotension (IDH), nausea, central nervous system dysfunction, cramping, and risks compromising vascular access and worsening residual renal function.(7) Determining the patients' accurate dry weight is essential to minimizing these issues. When dry weight is accurately determined, quick variations in blood volume are avoided, which lowers the risk of problems during haemodialysis(8). The measurement of arterial natriuretic peptide (half-life of approximately 2 to 4 minutes), cyclic guanidine monophosphate, the diameter of the inferior vena cava (by echocardiography), bioimpedance (based on resistance measurement), and blood volume (by tracking changes in serum protein and hemoglobin) are used to determine dry weight.(9, 10) These techniques frequently need specialized equipment and are expensive. However, one practical way to measure dry weight prior to dialysis is to measure the amount of sodium, the most prevalent cation in extracellular fluid .(11)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of measurement of dry weight based on pre dialysis serum sodium measurment on reduction of h | Experimental | Other: serum sodium measurmentmeasurement of dry weight based on pre dialysis serum sodium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 6- not dependent to mechanical ventilation
- at least one year history of hemodialysis
- adults aged 18 to 65 years old
- ability to communicate verbally
- with no history of diabetes mellitus, urinary incontinence syndrome, heart and liver failure, and adrenal hypertrophy 5 -no use of antihypertensive and antispasmodic drugs four hours before dialysis
Key exclusion criteria (2 listed)
- 1- Impaired consciousness 2- participant's withdrawal from the study 5-death 3- severe blood supply problem in the fistula or vascular access 4-migration or travel during the study
- -
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 |
|---|---|---|
| serum sodium measurmentserum sodium measurment | Other | Effect of measurement of dry weight based on pre dialysis serum sodium measurment on reduction of h |
Primary outcome
predict correlation between accurate measurement of dry weight in kilogram by predialytic serum sodium level and incidence of complications.
Time frame: 3 month ( 39 session for each patient , 13 session per month)
We aimed to determine the effect of assessment of dry weight based on measuring blood sodium level before dialysis to evaluate the effect of adjustment of ultrafilteration rate on haemodialysis complications and take a step forward to improve patient care and the quality of hemodialysis
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 8 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing serum sodium measurment in people with Dialysis Related Complication, run by Assiut University.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predict correlation between accurate measurement of dry weight in kilogram by predialytic serum sodium level and incidence of complications. (time frame: 3 month ( 39 session for each patient , 13 session per month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2025.