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NCT07022847Recruiting

Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis

The Value of Pleth Variability Index in Predicting Hypotension During Maintenance Hemodialysis: A Prospective Observational Multicenter Study

Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
7 Jun 2025
Start date
Feb 2025
Primary completion date
Jun 2025
Lead sponsor
First Affiliated Hospital of Wannan Medical College
NCT number
NCT07022847

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From Feb 2025 to the primary completion date, Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • Known allergy or contraindication to materials used in the hemodialysis circuit.

Other

  • Pregnant or breastfeeding women.
  • Unable to cooperate with study procedures.
  • Participation in another interventional clinical study within the past 30 days.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Coordinator of this site? Confirm its status
WuhuChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.