Pleth Variability Index to predict low blood pressure during maintenance hemodialysis

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

This will test whether a simple pulse-oximeter reading (PVI) can help predict which adults on routine hemodialysis will develop low blood pressure so clinicians can act earlier.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Wannan Medical College (Academic / other)
• Locations: 1 site (Wuhu, Anhui)
• Trial ID: NCT07022847 on ClinicalTrials.gov

What this trial studies

This observational study will record Pleth Variability Index (PVI) values noninvasively from a pulse oximeter during regular maintenance hemodialysis sessions in adults. Participants are adults aged 18–80 who have been on thrice- or regularly scheduled hemodialysis for more than three months, with exclusions for severe arrhythmias, major peripheral vascular disease, or local conditions preventing accurate PVI measurement. Investigators will compare PVI trends and pre-dialysis or intra-dialytic clinical data with episodes of intradialytic hypotension to determine predictive relationships. The goal is to determine whether PVI readings can reliably flag patients at higher short-term risk of low blood pressure during dialysis.

Who should consider this trial

Good fit: Adults aged 18 to 80 who have been receiving maintenance hemodialysis for more than three months and who can give informed consent and cooperate with monitoring are ideal candidates.

Not a fit: Patients with severe cardiac arrhythmias, significant peripheral vascular disease or local edema that prevents accurate PVI measurement, pregnant or breastfeeding women, or those allergic to dialysis circuit materials may not receive benefit from PVI monitoring.

Why it matters

Potential benefit: If successful, noninvasive PVI monitoring could give clinicians an early warning of patients at risk for intradialytic hypotension, allowing preventive steps to reduce symptoms and complications.

How similar studies have performed: PVI has shown usefulness for predicting fluid responsiveness in surgical and critical care settings, but its application to predicting intradialytic hypotension is relatively novel with limited and mixed observational evidence.

Eligibility criteria

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.

Where this trial is running

Wuhu, Anhui

• The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) — Wuhu, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Qiancheng Xu

Conditions Hypotension and Shock; Hemodialysis; End-Stage Renal Disease Requiring Haemodialysis; Intradialytic Hypotension; Pleth Variability Index; Blood Pressure Monitoring; End-Stage Renal Disease; Non-invasive Monitoring