RecruitingNCT07022847

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


Sponsor

First Affiliated Hospital of Wannan Medical College

Enrollment

200 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

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. 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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a painless sensor clipped to your finger (called a pleth variability index device) can predict blood pressure drops during regular dialysis sessions in patients with kidney failure. **You may be eligible if...** - You are between 18 and 80 years old - You have end-stage kidney disease (your kidneys have stopped working) - You have been receiving regular dialysis for at least 3 months - You are willing and able to give consent and follow study procedures **You may NOT be eligible if...** - You have severe heart rhythm problems or significant circulation issues in your limbs - You have swelling, skin wounds, or other issues on your finger that would prevent the sensor from working - You have a history of unstable blood pressure unrelated to dialysis - You are pregnant or breastfeeding - You have a known allergy to dialysis materials - You participated in another interventional study in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-invasive Monitoring

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.


Locations(1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, China

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NCT07022847


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