Clinical trial NCT07022847: Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis
Official title: The Value of Pleth Variability Index in Predicting Hypotension During Maintenance Hemodialysis: A Prospective Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypotension and Shock
Hemodialysis
End-Stage Renal Disease Requiring Haemodialysis
Intradialytic Hypotension
Keywords: Pleth Variability Index
Hemodialysis
Intradialytic Hypotension
Blood Pressure Monitoring
End-Stage Renal Disease
Non-invasive Monitoring
Predictive Marker
Maintenance Dialysis
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
Collaborators: name: Wuhu City Second People's Hospital
name: Wuhu Hospital of Chinese Traditional Medicine
First posted: 2025-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients aged 18 to 80 years with end-stage renal disease who have been receiving maintenance hemodialysis for more than three months at participating dialysis centers. Participants are required to be able to provide informed consent and cooperate with study procedures.

Brief 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 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.

Primary outcomes:
measure: Predictive Value of PVI for Intradialytic Hypotension
timeFrame: Pre-dialysis (baseline), and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
measure: Predictive Value of Percentage Change in Pleth Variability Index (%PVi) for Intradialytic Hypotension
timeFrame: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
Secondary outcomes:
measure: Incidence of Intradialytic Hypotension
timeFrame: Up to 1 dialysis session (4 hours)
measure: Predictive Value of Change in Pleth Variability Index (dPVi) for Intradialytic Hypotension
timeFrame: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
measure: Correlation Between PVI, dPVi, %PVi and Changes in Blood Pressure
timeFrame: Pre-dialysis (baseline) and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
state: Anhui
Study officials:
References: