Hemodialysis-Induced SymptomNCT03037138
Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients
A study testing Blood flow Rate profiling in people with Hemodialysis-Induced Symptom, run by Benha University.
Trial summary
Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis washed-out state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis-Induced Symptom
- What is being tested?
- Blood flow Rate profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2016to 1 Jan 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis Patient
- Postdialysis washed-out complain
Who cannot join
- schedule-non complaint patients
- Patients with recent blood pressure drug modification
About this study
Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis washed-out state.
Read the detailed description
Hemodialysis patients who complain of the postdialysis washed-out state were recruited. blood flow rate was altered to be 350 ml/min in the first hour of the session then decreased by 50 ml/min hourly for the 4-hour dialysis session. blood flow rate profiling was continued for 9 dialysis sessions (21 Days). Patients were asked to grade their washed-out state on a scale from 1 (no washed-out state) to 5 (severe washed-out state) before and after blood flow rate profiling. Paired t=-test and Wilcoxon Signed Ranks Test were used in appropriate context to compare washed out scale before and after together with urea reduction rate and other blood chemistry tests.
- Conditions
- Hemodialysis-Induced Symptom
- Being tested
- Blood flow Rate profiling
- Keywords
- postdialysis washed-out
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow Rate profilingOther
Blood flow rate profiling during dialysis session
| Study group | Role | What they receive |
|---|---|---|
| Washed-out scale after using BFR profiling | Other | Blood flow profiling will be used as intervention for washed-out dialysis patients Receives: Other: Blood flow Rate profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Washed-out Scale
Scale of washed-out degree after dialysis
Measured: after 9 modified dialysis session (21 dyas from start of study)
Secondary outcomes (1)
Urea reduction Rate
change in urea reduction rate after use of blood flow rate profiling
Measured: after 9 modified dialysis session (21 dyas from start of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start12 Nov 2016
- Primary completion5 Dec 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis-Induced SymptomStudies of the same condition, open and under way.
- More trials run by Benha 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
- Model description
- Use of blood flow profiling for prevention of postdialysis washed-out feeling through same group scale before and after profiling
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037138
- Sponsor's protocol ID
- BenhaU
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients
- ClinicalTrials.gov ID
- NCT03037138
- Acronym / sponsor ID
- BenhaU
- Conditions
- Hemodialysis-Induced Symptom
- Keywords
- postdialysis washed-out
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Study start
- 12 Nov 2016 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis washed-out state.
Detailed description
Hemodialysis patients who complain of the postdialysis washed-out state were recruited. blood flow rate was altered to be 350 ml/min in the first hour of the session then decreased by 50 ml/min hourly for the 4-hour dialysis session. blood flow rate profiling was continued for 9 dialysis sessions (21 Days). Patients were asked to grade their washed-out state on a scale from 1 (no washed-out state) to 5 (severe washed-out state) before and after blood flow rate profiling. Paired t=-test and Wilcoxon Signed Ranks Test were used in appropriate context to compare washed out scale before and after together with urea reduction rate and other blood chemistry tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Use of blood flow profiling for prevention of postdialysis washed-out feeling through same group scale before and after profiling
| Arm | Type | Receives |
|---|---|---|
| Washed-out scale after using BFR profiling | Other | Other: Blood flow Rate profilingBlood flow profiling will be used as intervention for washed-out dialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemodialysis Patient
- Postdialysis washed-out complain
Key exclusion criteria (2 listed)
- schedule-non complaint patients
- Patients with recent blood pressure drug modification
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 |
|---|---|---|
| Blood flow Rate profilingBlood flow rate profiling during dialysis session | Other | Washed-out scale after using BFR profiling |
Primary outcome
Washed-out Scale
Time frame: after 9 modified dialysis session (21 dyas from start of study)
Scale of washed-out degree after dialysis
1 secondary outcome
Urea reduction Rate
Time frame: after 9 modified dialysis session (21 dyas from start of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: No
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.
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 Blood flow Rate profiling in people with Hemodialysis-Induced Symptom, run by Benha 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: finished, as of the sponsor's last update on 31 Jan 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Washed-out Scale (time frame: after 9 modified dialysis session (21 dyas from start of study)). 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 31 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.