Intradialytic HypotensionCUPIDNCT07033260
Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension
An observational study of Intradialytic Hypotension and End-Stage Renal Disease Requiring Haemodialysis, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intradialytic Hypotension, End-Stage Renal Disease Requiring Haemodialysis, Uremia; Chronic
- What is being tested?
- Non-invasive Monitoring
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Aug 2025
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Adult patients aged 18 to 80 years with end-stage renal disease who have been receiving maintenance hemodialysis for more than three months at participating dialysis centers. Participants are required to be able to provide informed consent and cooperate with study procedures.
Who may be able to join
- Adults aged 18 to 80 years. Diagnosed with end-stage renal disease (ESRD). Undergoing maintenance hemodialysis for more than three months. Willing and able to provide informed consent and comply with study procedures.
Who cannot join
- Patients with significant carotid artery stenosis due to heavy atherosclerotic plaque (defined as more than 70% stenosis confirmed by ultrasound or angiography).
- Hemodynamically unstable patients or those requiring vasopressor support. Patients with significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia).
- Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).
- Use of antihypertensive medications during dialysis sessions. Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.
- Patients who withdraw informed consent during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Outside of the US, 241000
Shengsheng Tao, 86-18315329399, qianchengxu@wnmc.edu.cn
About this study
Official title: The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study
This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.
- Conditions
- Intradialytic Hypotension, End-Stage Renal Disease Requiring Haemodialysis, Uremia; Chronic, Hemodialysis
- Being tested
- Non-invasive Monitoring
- Keywords
- Carotid ultrasonography, Corrected flow time, Peak flow velocity variability, Intradialytic hypotension, Hemodialysis, Ultrasonographic predictors, Vascular ultrasonography, Fluid management, Dialysis safety
- Medical subject headings
- Uremia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive MonitoringOther
All participants will undergo non-invasive ultrasonographic measurement of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) before and during hemodialysis sessions. No treatment or experimental intervention will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Hemodialysis Patients | Adult patients aged 18 to 80 years undergoing maintenance hemodialysis for more than three months. All participants will undergo carotid ultrasonography to measure corrected flow time (FTc) and peak flow velocity variability (PFVV) during routine dialysis sessions. The study aims to evaluate the association between these ultrasonographic parameters and the occurrence of intradialytic hypotension. Receives: Other: Non-invasive Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of Carotid Corrected Flow Time (FTc) for Intradialytic Hypotension
The carotid corrected flow time (FTc) is the duration of blood flow in the carotid artery, corrected for heart rate, measured using ultrasonography at 1 hour after hemodialysis initiation. This parameter will be evaluated for its ability to predict hypotension episodes during dialysis, with analysis focusing on sensitivity, specificity, and ROC curve to determine diagnostic accuracy.
Measured: 1 hour after dialysis start during a single session.
Predictive Value of Peak Flow Velocity Variability (PFVV) for Intradialytic Hypotension
PFVV represents the variation in peak flow velocity in the carotid artery measured by ultrasonography at 1 hour after hemodialysis start. It reflects vascular volume status and elastic properties. Its capacity to predict intradialytic hypotension will be assessed through sensitivity, specificity, and ROC analysis.
Measured: 1 hour after dialysis start during a single session.
Secondary outcomes (2)
Incidence of Intradialytic Hypotension
The proportion of dialysis sessions in which patients experience hypotension, defined as a decrease in systolic blood pressure (SBP) of 20 mmHg or more during the session, will be recorded to estimate clinical event frequency.
Measured: Up to 1 dialysis session (4 hours)
Correlation Between FTc and PFVV and Changes in Blood Pressure
Assessment of the statistical correlation between PVI parameters ( FTc and PFVV) and changes in blood pressure, including systolic blood pressure, diastolic blood pressure, and mean arterial pressure, during the dialysis session.
Measured: 1 hour after dialysis start during a single hemodialysis session (total duration up to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Feb 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhu City Second People's Hospital, Wuhu County Traditional Chinese Medicine Hospital
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033260
- Sponsor's protocol ID
- 2025-12
- Acronym
- CUPID
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 24 Jun 2025
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07033260
- Acronym / sponsor ID
- CUPID / 2025-12
- Conditions
- Intradialytic Hypotension, End-Stage Renal Disease Requiring Haemodialysis, Uremia; Chronic, Hemodialysis
- Keywords
- Carotid ultrasonography, Corrected flow time, Peak flow velocity variability, Intradialytic hypotension, Hemodialysis, Ultrasonographic predictors, Vascular ultrasonography, Fluid management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- Wuhu City Second People's Hospital, Wuhu County Traditional Chinese Medicine Hospital
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 24 Jun 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.
This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance Hemodialysis Patients | – | Other: Non-invasive MonitoringAdult patients aged 18 to 80 years undergoing maintenance hemodialysis for more than three months. All participants will undergo carotid ultrasonography to measure corrected flow time (FTc) and peak flow velocity variability (PFVV) during routine dialysis sessions. The study aims to evaluate the association between these ultrasonographic parameters and the occurrence of intradialytic hypotension. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 80 years with end-stage renal disease who have been receiving maintenance hemodialysis for more than three months at participating dialysis centers. Participants are required to be able to provide informed consent and cooperate with study procedures.
Key inclusion criteria (1 listed)
- Adults aged 18 to 80 years. Diagnosed with end-stage renal disease (ESRD). Undergoing maintenance hemodialysis for more than three months. Willing and able to provide informed consent and comply with study procedures.
Key exclusion criteria (5 listed)
- Patients with significant carotid artery stenosis due to heavy atherosclerotic plaque (defined as more than 70% stenosis confirmed by ultrasound or angiography).
- Hemodynamically unstable patients or those requiring vasopressor support. Patients with significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia).
- Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).
- Use of antihypertensive medications during dialysis sessions. Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.
- Patients who withdraw informed consent 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 |
|---|---|---|
| Non-invasive MonitoringAll participants will undergo non-invasive ultrasonographic measurement of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) before and during hemodialysis sessions. No treatment or experimental intervention will be applied. | Other | Maintenance Hemodialysis Patients |
Primary outcome
Predictive Value of Carotid Corrected Flow Time (FTc) for Intradialytic Hypotension
Time frame: 1 hour after dialysis start during a single session.
The carotid corrected flow time (FTc) is the duration of blood flow in the carotid artery, corrected for heart rate, measured using ultrasonography at 1 hour after hemodialysis initiation. This parameter will be evaluated for its ability to predict hypotension episodes during dialysis, with analysis focusing on sensitivity, specificity, and ROC curve to determine diagnostic accuracy.
Predictive Value of Peak Flow Velocity Variability (PFVV) for Intradialytic Hypotension
Time frame: 1 hour after dialysis start during a single session.
PFVV represents the variation in peak flow velocity in the carotid artery measured by ultrasonography at 1 hour after hemodialysis start. It reflects vascular volume status and elastic properties. Its capacity to predict intradialytic hypotension will be assessed through sensitivity, specificity, and ROC analysis.
2 secondary outcomes
Incidence of Intradialytic Hypotension
Time frame: Up to 1 dialysis session (4 hours)
Correlation Between FTc and PFVV and Changes in Blood Pressure
Time frame: 1 hour after dialysis start during a single hemodialysis session (total duration up to 4 hours)
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 24 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intradialytic Hypotension and End-Stage Renal Disease Requiring Haemodialysis, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
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 1 inclusion and 5 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Qiancheng Xu (86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Value of Carotid Corrected Flow Time (FTc) for Intradialytic Hypotension (time frame: 1 hour after dialysis start during a single session.). 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?
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 24 Jun 2025.