End-stage Renal DiseaseHD-RPCNCT06587997
Changes in Renal Perfusion During Hemodialysis in Patients with End-stage Renal Disease
An observational study of End-stage Renal Disease, run by Yuanjun Yang.
Trial summary
Residual renal function (RRF) characteristically declines after patients with end-stage renal disease (ESRD) initiate dialysis. Although RRF preservation correlates with improved patient\'s quality of life and survival prospects, poor understanding of the pathophysiology underlying RRF decline limits… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2024to 3 Sep 2026
- How long will I take part?
- 10 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First Medical Center of Chinese PLA General Hospital
Who may be able to join
- Age ≥ 18 years;
- Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
- Urine output \> 500ml/day or GFR \> 3ml/min/1.72m2;
- Signed and dated informed consented is obtained.
Who cannot join
- Presence of vascular access dysfunction (blood flow rate \< 180ml/min);
- Severe heart failure;
- Active infection;
- Infectious disease;
- Patients with severe anemia;
- Patients with polycystic kidney disease;
Show all 11Show fewer
- Expected dialysis duration \< 6 months;
- Pregnancy or lactation women;
- Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
- Unwillingness to be followed up or poor adherence to treatment;
- Other circumstances that the investigator considers unsuitable for enrolment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes in Renal Perfusion During Hemodialysis in Patients with End-stage Renal Disease: a Prospective Observational Study
Residual renal function (RRF) characteristically declines after patients with end-stage renal disease (ESRD) initiate dialysis. Although RRF preservation correlates with improved patient\&#39;s quality of life and survival prospects, poor understanding of the pathophysiology underlying RRF decline limits protection strategies.
Read the detailed description
Hemodialysis (HD) is the primary renal replacement therapy for patients with end-stage renal disease. However, residual renal function (RRF) characteristically declines after these individuals start dialysis. This loss of RRF not only impacts the adequacy of dialysis and control of complications but also affects the patient\&#39;s quality of life and survival prospects. Due to a lack of clear understanding regarding the pathophysiology underlying this decline in RRF, no effective strategies exist for its preservation at present. The objective of this study is to explore the changes in renal perfusion during hemodialysis in patients with end-stage renal disease, and provide a new idea for protection of RRF. This study was an observational study, and no interventions were performed.
- Conditions
- End-stage Renal Disease
- Keywords
- hemodialysis, renal perfusion, end-stage renal disease
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
renal perfusion
Changes in renal perfusion during hemodialysis in patients with end-stage renal disease
Measured: one day
Secondary outcomes (3)
diastolic blood pressure
diastolic blood pressure during hemodialysis in patients with end-stage renal disease
Measured: one day
systolic blood pressure
systolic blood pressure during hemodialysis in patients with end-stage renal disease
Measured: one day
urine volume
Urine volume within 10 months of starting dialysis
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Sep 2024 (estimated)
- Primary completion3 Sep 2026 (estimated)
- Study completion3 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Yuanjun Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanjun Yang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587997
- Sponsor's protocol ID
- HD-RPC
- Acronym
- HD-RPC
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Renal Perfusion During Hemodialysis in Patients with End-stage Renal Disease: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06587997
- Acronym / sponsor ID
- HD-RPC / HD-RPC
- Conditions
- End-stage Renal Disease
- Keywords
- hemodialysis, renal perfusion, end-stage renal disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yuanjun YangUniversity, hospital or other
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 3 Sep 2026 (estimated)
- First posted
- 19 Sep 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.
Residual renal function (RRF) characteristically declines after patients with end-stage renal disease (ESRD) initiate dialysis. Although RRF preservation correlates with improved patient\&#39;s quality of life and survival prospects, poor understanding of the pathophysiology underlying RRF decline limits protection strategies.
Detailed description
Hemodialysis (HD) is the primary renal replacement therapy for patients with end-stage renal disease. However, residual renal function (RRF) characteristically declines after these individuals start dialysis. This loss of RRF not only impacts the adequacy of dialysis and control of complications but also affects the patient\&#39;s quality of life and survival prospects. Due to a lack of clear understanding regarding the pathophysiology underlying this decline in RRF, no effective strategies exist for its preservation at present. The objective of this study is to explore the changes in renal perfusion during hemodialysis in patients with end-stage renal disease, and provide a new idea for protection of RRF. This study was an observational study, and no interventions were performed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First Medical Center of Chinese PLA General Hospital
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
- Urine output \> 500ml/day or GFR \> 3ml/min/1.72m2;
- Signed and dated informed consented is obtained.
Key exclusion criteria (11 listed)
- Presence of vascular access dysfunction (blood flow rate \< 180ml/min);
- Severe heart failure;
- Active infection;
- Infectious disease;
- Patients with severe anemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
renal perfusion
Time frame: one day
Changes in renal perfusion during hemodialysis in patients with end-stage renal disease
3 secondary outcomes
diastolic blood pressure
Time frame: one day
systolic blood pressure
Time frame: one day
urine volume
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Yuanjun Yang.
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 4 inclusion and 11 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 Sep 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 Dayang Xie (13718941415, 460436948@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal perfusion (time frame: one day). 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 19 Sep 2024.