Dialysis; ComplicationsNCT06213129
Effect of Sodium and UF Profiling on Dialysis
An observational study of Dialysis; Complications, run by Assiut University.
Trial summary
The aim of this study is to evaluate the effects of sodium and UF profiling on hemodynamic stability, interdialytic weight gain, and intradialytic complications Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- Na and ultrafiltration profiling
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Adult, Older adult
Study population: End-stage renal disease on regular HD
Who may be able to join
- End-stage renal disease patients.
- Patients on regular hemodialysis
Who cannot join
- Patients who refuse to contribute in this study.
- Hemodynamically unstable patients.
Trial locations and contacts
No sites are listed yet.
Ragda Hassan, 3 contact
About this study
Official title: Effect of Sodium and Ultrafiltration Profiling on Hemodynamic Stability, Interdialytic Weight Gain, and Intradialytic Complications.
The aim of this study is to evaluate the effects of sodium and UF profiling on hemodynamic stability, interdialytic weight gain, and intradialytic complications
Read the detailed description
Sodium and ultrafiltration profiling are method of dialysis in which dialysate sodium concentration and ultrafiltration rate are altered during the course of the dialysis session.
Several sodium profiling methods are available. Increasing, decreasing, or alternating sodium concentrations may be used, although decreasing profiling has been the most accepted. The decrease in dialysate sodium concentration may be linear, stepwise, or exponential As different sodium profiling methods may have distinct impacts, different dialysis modalities may also affect the outcome of profiling. Although not as commonly used, hemodiafiltration HDF which utilizes convective clearance in addition to diffusion, may change the results of sodium profiling Such intervention alleviates the acute decline in intravascular volume during ultrafiltration UF as well as the decline in intradialytic plasma osmolarity and the consequent disequilibrium syndrome Sodium profiling enhances the internal plasma refill rate and helps to stabilize the blood pressure, thus decreasing the risk of Intra dialytic hypotension. It is imperative to limit or prevent intradialytic hypotension since it does not only affect the patient's comfort but also increases the risk of vascular access thrombosis, myocardial fibrosis and stunning, cardiovascular events, and mortality So it has potential benefits in terms of intradialytic morbidity and mortality as well as quality of life and long-term cardiovascular events; nevertheless, it may also predispose to interdialytic hypernatremia and increased interdialytic hypernatremia and interdialytic weight gain IDWG and hypertension. Fatigue and thirst have been reported with sodium profiling and the resulting sodium overload.
Another method to avoid intradialytic hemodynamic instability is UF profiling. In it, a larger portion of total UF volume is extracted during the first part of a dialysis session, after which the UF rate is decreased in order to maintain hemodynamic stability However, achieving a correct intradialytic sodium balance is a much more difficult task in clinical practice. With the advances in technology, automatic computer-based programs can be used today to calculate intradialytic sodium removal. These models use real-time data from patients and are being used to reach underdialysis sodium, weight in Kg, and blood volume targets. Such biofeedback systems enable to achieve sodium balance neutral sodium profile and UF profile automatically. Currently, there are various commercial dialysis systems that calculate dialysate and UF profiles with algorithms based on the prescribed decrease in body weight and sodium mass.
The aim of study to determine which specific profiling methods is more efficacious in preventing specific symptoms and which profiling method has the most utility in routine clinical practice. Furthermore, more qualitative data is warranted for subjective analysis of quality of life and personal well-being.
- Conditions
- Dialysis; Complications
- Being tested
- Na and ultrafiltration profiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Na and ultrafiltration profilingDevice
Sodium and ultrafiltration profiling are method of dialysis in which dialysate sodium concentration and ultrafiltration rate are altered during the course of the dialysis session
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic and diastolic blood pressure
The primary outcome is systolic blood pressure (80 _130)mmhg and diastolic blood pressure within range (60_80)mmhg, A blood pressure within this range is considered indicative of a better health outcome for the purposes of our research
Measured: 2 weeks
Dialysis symptoms index
The Dialysis Symptom Index is a validated instrument to assess CKD-related unpleasant symptoms, and it is comprised of 30 questions about the presence of specifc symptoms For each question querying presence vs. absence of a specifc symptom, symptom severity is assessed using a five-point Likert scale, with each response ranging from 0 to 4 (i.e., a response of "0" indicates "no," whereas a response of "4" indicates "yes: very much"). The minimum-maxi- mum Dialysis Symptom Index score ranges from 0 to 120,with higher scores indicating worse outcome
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Hassan, Assiut University
- Investigators
- youssef Saleh, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213129
- Sponsor's protocol ID
- Na and UF profiling on ESRD
- Status last verified
- Jan 2024
- First submitted
- 18 Sep 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coli L, La Manna G, Dalmastri V, De Pascalis A, Pace G, Santese G, Stefanio C, Ursino M, Zaca F, Stefoni S. Evidence of profiled hemodialysis efficacy in the treatment of intradialytic hypotension. Int J Artif Organs. 1998 Jul;21(7):398-402.
PubMed 9745994
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium and Ultrafiltration Profiling on Hemodynamic Stability, Interdialytic Weight Gain, and Intradialytic Complications.
- ClinicalTrials.gov ID
- NCT06213129
- Acronym / sponsor ID
- Na and UF profiling on ESRD
- Conditions
- Dialysis; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Aug 2024 (estimated)
- First posted
- 19 Jan 2024 (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.
The aim of this study is to evaluate the effects of sodium and UF profiling on hemodynamic stability, interdialytic weight gain, and intradialytic complications
Detailed description
Sodium and ultrafiltration profiling are method of dialysis in which dialysate sodium concentration and ultrafiltration rate are altered during the course of the dialysis session.
Several sodium profiling methods are available. Increasing, decreasing, or alternating sodium concentrations may be used, although decreasing profiling has been the most accepted. The decrease in dialysate sodium concentration may be linear, stepwise, or exponential As different sodium profiling methods may have distinct impacts, different dialysis modalities may also affect the outcome of profiling. Although not as commonly used, hemodiafiltration HDF which utilizes convective clearance in addition to diffusion, may change the results of sodium profiling Such intervention alleviates the acute decline in intravascular volume during ultrafiltration UF as well as the decline in intradialytic plasma osmolarity and the consequent disequilibrium syndrome Sodium profiling enhances the internal plasma refill rate and helps to stabilize the blood pressure, thus decreasing the risk of Intra dialytic hypotension. It is imperative to limit or prevent intradialytic hypotension since it does not only affect the patient's comfort but also increases the risk of vascular access thrombosis, myocardial fibrosis and stunning, cardiovascular events, and mortality So it has potential benefits in terms of intradialytic morbidity and mortality as well as quality of life and long-term cardiovascular events; nevertheless, it may also predispose to interdialytic hypernatremia and increased interdialytic hypernatremia and interdialytic weight gain IDWG and hypertension. Fatigue and thirst have been reported with sodium profiling and the resulting sodium overload.
Another method to avoid intradialytic hemodynamic instability is UF profiling. In it, a larger portion of total UF volume is extracted during the first part of a dialysis session, after which the UF rate is decreased in order to maintain hemodynamic stability However, achieving a correct intradialytic sodium balance is a much more difficult task in clinical practice. With the advances in technology, automatic computer-based programs can be used today to calculate intradialytic sodium removal. These models use real-time data from patients and are being used to reach underdialysis sodium, weight in Kg, and blood volume targets. Such biofeedback systems enable to achieve sodium balance neutral sodium profile and UF profile automatically. Currently, there are various commercial dialysis systems that calculate dialysate and UF profiles with algorithms based on the prescribed decrease in body weight and sodium mass.
The aim of study to determine which specific profiling methods is more efficacious in preventing specific symptoms and which profiling method has the most utility in routine clinical practice. Furthermore, more qualitative data is warranted for subjective analysis of quality of life and personal well-being.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease on regular HD
Key inclusion criteria (2 listed)
- End-stage renal disease patients.
- Patients on regular hemodialysis
Key exclusion criteria (2 listed)
- Patients who refuse to contribute in this study.
- Hemodynamically unstable patients.
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 |
|---|---|---|
| Na and ultrafiltration profilingSodium and ultrafiltration profiling are method of dialysis in which dialysate sodium concentration and ultrafiltration rate are altered during the course of the dialysis session | Device | – |
Primary outcome
systolic and diastolic blood pressure
Time frame: 2 weeks
The primary outcome is systolic blood pressure (80 _130)mmhg and diastolic blood pressure within range (60_80)mmhg, A blood pressure within this range is considered indicative of a better health outcome for the purposes of our research
Dialysis symptoms index
Time frame: 2 weeks
The Dialysis Symptom Index is a validated instrument to assess CKD-related unpleasant symptoms, and it is comprised of 30 questions about the presence of specifc symptoms For each question querying presence vs. absence of a specifc symptom, symptom severity is assessed using a five-point Likert scale, with each response ranging from 0 to 4 (i.e., a response of "0" indicates "no," whereas a response of "4" indicates "yes: very much"). The minimum-maxi- mum Dialysis Symptom Index score ranges from 0 to 120,with higher scores indicating worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 9745994Coli L, La Manna G, Dalmastri V, De Pascalis A, Pace G, Santese G, Stefanio C, Ursino M, Zaca F, Stefoni S. Evidence of profiled hemodialysis efficacy in the treatment of intradialytic hypotension. Int J Artif Organs. 1998 Jul;21(7):398-402.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ragda Hassan, 3 contact
youssef Saleh principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis; Complications, 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 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neveen Hassan (01069309948, nivoh86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic and diastolic blood pressure (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT06213129, which also lists 1 linked publication.
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 19 Jan 2024.