Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis (PVI-HD)

First Affiliated Hospital of Wannan Medical College

Status: Enrolling

Conditions: Hemodialysis; End-Stage Renal Disease Requiring Haemodialysis; Hypotension and Shock; Intradialytic Hypotension

Treatments: Other: Non-invasive Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT07022847

2025-61

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

200 participants in 1 patient group

Maintenance Hemodialysis Patients

Description:

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.

Treatment:

Other: Non-invasive Monitoring