Hypotension and ShockPVI-HDNCT07022847
Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis
An observational study of Hypotension and Shock and Hemodialysis, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
What is this study about? We are studying whether the Pleth Variability Index (PVI)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. Low blood pressure during dialysis is a common and potentially serious complication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypotension and Shock, Hemodialysis, End-Stage Renal Disease Requiring Haemodialysis
- What is being tested?
- Non-invasive Monitoring
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Jun 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
- No healthy volunteers
- 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.
- Diagnosis of end-stage renal disease and undergoing maintenance hemodialysis for more than 3 months.
- Able and willing to provide informed consent and comply with study procedures.
Who cannot join
- Severe cardiac arrhythmias or significant peripheral vascular disease that may interfere with PVI measurements.
- Local edema, skin lesions, or other conditions that prevent accurate PVI monitoring.
- History of hemodynamic instability unrelated to dialysis.
- Pregnant or breastfeeding women.
- Known allergy or contraindication to materials used in the hemodialysis circuit.
- Unable to cooperate with study procedures.
- Participation in another interventional clinical study within the past 30 days.
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, Anhui, 241000
Shengsheng Tao, 86-18315329399, taoshengsheng@yjsyy.com
About this study
Official title: The Value of Pleth Variability Index in Predicting Hypotension During Maintenance Hemodialysis: A Prospective Observational Multicenter Study
What is this study about? We are studying whether the Pleth Variability Index (PVI)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. Low blood pressure during dialysis is a common and potentially serious complication. Our goal is to find out if monitoring PVI can help identify patients at risk, so that early action can be taken.
Who can join? Adults aged 18 to 80 years. Patients who have been receiving maintenance hemodialysis regularly for more than 3 months.
Read more
Those who are willing and able to participate and sign an informed consent form.
Who cannot join? Patients with severe heart rhythm problems, severe peripheral circulation problems, or swelling that makes PVI measurement unreliable.
Patients who are pregnant or breastfeeding. Patients allergic to the dialysis filter or unable to cooperate with the study procedures.
What will happen during the study? PVI Measurement: Your PVI will be checked with a simple fingertip device before starting dialysis and again 30 minutes after dialysis begins.
Blood Pressure Monitoring: Your blood pressure will be closely watched throughout the dialysis session.
Data Collection: Information about your age, medical history, medications, lab results, dialysis settings, and other standard measurements will be recorded.
What are the benefits and risks? Benefits: By identifying patients at higher risk for low blood pressure during dialysis, the study may lead to safer and more comfortable dialysis treatment in the future.
Risks: All measurements used in this study are safe and non-invasive, with no extra risk compared to routine care.
Your Rights and Safety Participation is completely voluntary-you may leave the study at any time without affecting your medical care.
The study has been reviewed and approved by the hospital's ethics committee. Your privacy and personal data will be strictly protected.
- Conditions
- Hypotension and Shock, Hemodialysis, End-Stage Renal Disease Requiring Haemodialysis, Intradialytic Hypotension
- Being tested
- Non-invasive Monitoring
- Keywords
- Pleth Variability Index, Hemodialysis, Intradialytic Hypotension, Blood Pressure Monitoring, End-Stage Renal Disease, Non-invasive Monitoring, Predictive Marker, Maintenance Dialysis
- Medical subject headings
- Hypotension, Shock, Kidney Failure, Chronic
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 measurement of Pleth Variability Index (PVI) and routine blood pressure monitoring 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 who have been receiving maintenance hemodialysis for more than 3 months. All participants will be monitored for blood pressure and Pleth Variability Index (PVI) measurements before and during hemodialysis sessions. The occurrence of intradialytic hypotension and its association with PVI will be evaluated. 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 PVI for Intradialytic Hypotension
PVI measured at baseline (pre-dialysis) and at 60 minutes after the start of hemodialysis.
The sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve of PVI measured before and during hemodialysis in predicting hypotension events.
Measured: Pre-dialysis (baseline), and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
Predictive Value of Percentage Change in Pleth Variability Index (%PVi) for Intradialytic Hypotension
The ability of the percentage change in PVI (%PVi) between pre-dialysis and 60minutes after the start of dialysis to predict intradialytic hypotension. This will be evaluated using sensitivity, specificity, and area under the ROC curve analysis.
Measured: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
Secondary outcomes (3)
Incidence of Intradialytic Hypotension
The proportion of hemodialysis treatments in which patients develop hypotension, defined as a decrease in systolic blood pressure of ≥20 mmHg
Measured: Up to 1 dialysis session (4 hours)
Predictive Value of Change in Pleth Variability Index (dPVi) for Intradialytic Hypotension
The ability of the absolute difference in PVI (dPVi) between pre-dialysis and 60minutes after the start of dialysis to predict intradialytic hypotension. This will be evaluated using sensitivity, specificity, and area under the ROC curve analysis.
Measured: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
Correlation Between PVI, dPVi, %PVi and Changes in Blood Pressure
Assessment of the statistical correlation between PVI parameters (PVI, dPVi, and %PVi) and changes in blood pressure, including systolic blood pressure, diastolic blood pressure, and mean arterial pressure, during the dialysis session. Blood pressure changes will be calculated as the difference between pre-dialysis (baseline) and corresponding post-initiation time points (60 minutes). Correlation analyses will use Pearson or Spearman methods as appropriate.
Measured: Pre-dialysis (baseline) and 60 minutes after the start of 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 posted15 Jun 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension and ShockStudies 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
- 200 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
- NCT07022847
- Sponsor's protocol ID
- 2025-61
- Acronym
- PVI-HD
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 15 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Pleth Variability Index in Predicting Hypotension During Maintenance Hemodialysis: A Prospective Observational Multicenter Study
- ClinicalTrials.gov ID
- NCT07022847
- Acronym / sponsor ID
- PVI-HD / 2025-61
- Conditions
- Hypotension and Shock, Hemodialysis, End-Stage Renal Disease Requiring Haemodialysis, Intradialytic Hypotension
- Keywords
- Pleth Variability Index, Hemodialysis, Intradialytic Hypotension, Blood Pressure Monitoring, End-Stage Renal Disease, Non-invasive Monitoring, Predictive Marker, Maintenance Dialysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 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 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 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.
What is this study about? We are studying whether the Pleth Variability Index (PVI)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. Low blood pressure during dialysis is a common and potentially serious complication. Our goal is to find out if monitoring PVI can help identify patients at risk, so that early action can be taken.
Who can join? Adults aged 18 to 80 years. Patients who have been receiving maintenance hemodialysis regularly for more than 3 months.
Those who are willing and able to participate and sign an informed consent form.
Who cannot join? Patients with severe heart rhythm problems, severe peripheral circulation problems, or swelling that makes PVI measurement unreliable.
Patients who are pregnant or breastfeeding. Patients allergic to the dialysis filter or unable to cooperate with the study procedures.
What will happen during the study? PVI Measurement: Your PVI will be checked with a simple fingertip device before starting dialysis and again 30 minutes after dialysis begins.
Blood Pressure Monitoring: Your blood pressure will be closely watched throughout the dialysis session.
Data Collection: Information about your age, medical history, medications, lab results, dialysis settings, and other standard measurements will be recorded.
What are the benefits and risks? Benefits: By identifying patients at higher risk for low blood pressure during dialysis, the study may lead to safer and more comfortable dialysis treatment in the future.
Risks: All measurements used in this study are safe and non-invasive, with no extra risk compared to routine care.
Your Rights and Safety Participation is completely voluntary-you may leave the study at any time without affecting your medical care.
The study has been reviewed and approved by the hospital's ethics committee. Your privacy and personal data will be strictly protected.
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 who have been receiving maintenance hemodialysis for more than 3 months. All participants will be monitored for blood pressure and Pleth Variability Index (PVI) measurements before and during hemodialysis sessions. The occurrence of intradialytic hypotension and its association with PVI will be evaluated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 (3 listed)
- Adults aged 18 to 80 years.
- Diagnosis of end-stage renal disease and undergoing maintenance hemodialysis for more than 3 months.
- Able and willing to provide informed consent and comply with study procedures.
Key exclusion criteria (7 listed)
- Severe cardiac arrhythmias or significant peripheral vascular disease that may interfere with PVI measurements.
- Local edema, skin lesions, or other conditions that prevent accurate PVI monitoring.
- History of hemodynamic instability unrelated to dialysis.
- Pregnant or breastfeeding women.
- Known allergy or contraindication to materials used in the hemodialysis circuit.
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 measurement of Pleth Variability Index (PVI) and routine blood pressure monitoring before and during hemodialysis sessions. No treatment or experimental intervention will be applied. | Other | Maintenance Hemodialysis Patients |
Primary outcome
Predictive Value of PVI for Intradialytic Hypotension
Time frame: Pre-dialysis (baseline), and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
PVI measured at baseline (pre-dialysis) and at 60 minutes after the start of hemodialysis. The sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve of PVI measured before and during hemodialysis in predicting hypotension events.
Predictive Value of Percentage Change in Pleth Variability Index (%PVi) for Intradialytic Hypotension
Time frame: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
The ability of the percentage change in PVI (%PVi) between pre-dialysis and 60minutes after the start of dialysis to predict intradialytic hypotension. This will be evaluated using sensitivity, specificity, and area under the ROC curve analysis.
3 secondary outcomes
Incidence of Intradialytic Hypotension
Time frame: Up to 1 dialysis session (4 hours)
Predictive Value of Change in Pleth Variability Index (dPVi) for Intradialytic Hypotension
Time frame: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
Correlation Between PVI, dPVi, %PVi and Changes in Blood Pressure
Time frame: Pre-dialysis (baseline) and 60 minutes after the start of 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 15 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 Hypotension and Shock and Hemodialysis, 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 3 inclusion and 7 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 15 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 PVI for Intradialytic Hypotension (time frame: Pre-dialysis (baseline), and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).). 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 15 Jun 2025.