Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wannan Medical College

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Non-invasive Monitoring

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

First Affiliated Hospital of Wannan Medical College

Lead sponsor

Wuhu City Second People's Hospital

Collaborator

Wuhu County Traditional Chinese Medicine Hospital

Collaborator