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Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis

NCT07022847 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Hypotension and Shock
  • Hemodialysis
  • End-Stage Renal Disease Requiring Haemodialysis
  • Intradialytic Hypotension

Interventions

OTHER

Non-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.

Sponsors & Collaborators

  • Wuhu City Second People's Hospital

    collaborator OTHER

  • Wuhu County Traditional Chinese Medicine Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wannan Medical College

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022847 on ClinicalTrials.gov