Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07022847

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

Led by First Affiliated Hospital of Wannan Medical College · Updated on 2025-06-15

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Wannan Medical College

Lead Sponsor

W

Wuhu City Second People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether the Pleth Variability Index (PVI), a simple and non-invasive measurement from a pulse oximeter, can predict low blood pressure during routine maintenance hemodialysis. This is important because low blood pressure during dialysis is a common and potentially serious complication. The study focuses on adults aged 18 to 80 years who have been on maintenance hemodialysis for more than three months. All participants will have their PVI measured using a fingertip device before dialysis starts and again 30 minutes into the session. Blood pressure will be closely monitored throughout dialysis. No experimental treatments will be given, as this is an observational study. Researchers will collect data on participants' age, medical history, medications, lab results, and dialysis settings. During the study, participants will undergo PVI and blood pressure monitoring during a dialysis session lasting up to four hours. Researchers will analyze the predictive value of PVI and its changes for intradialytic hypotension. Participation is voluntary, with no extra risks beyond routine care. The study aims to improve safety during dialysis by identifying patients at risk for low blood pressure.

CONDITIONS

Brief Title

Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 4 hours per hemodialysis session

Participants who undergo maintenance hemodialysis are observed with non-invasive Pleth Variability Index (PVI) and routine blood pressure measurements before and during dialysis sessions.

1 hemodialysis session visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Wuhu, Anhui, China, 241000

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Research Team

Q

Qiancheng Xu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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