Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis

NCT07022847 | Recruiting

• 1 other identifier: 2025-61
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Predictive Value of PVI for Intradialytic Hypotension

  PVI measured at baseline (pre-dialysis) and at 60 minutes after the start of hemodialysis. The sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve of PVI measured before and during hemodialysis in predicting hypotension events.

  Pre-dialysis (baseline), and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).

• Predictive Value of Percentage Change in Pleth Variability Index (%PVi) for Intradialytic Hypotension

  The ability of the percentage change in PVI (%PVi) between pre-dialysis and 60minutes after the start of dialysis to predict intradialytic hypotension. This will be evaluated using sensitivity, specificity, and area under the ROC curve analysis.

  From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).

Secondary Outcomes (3)

• Incidence of Intradialytic Hypotension

  Up to 1 dialysis session (4 hours)

• Predictive Value of Change in Pleth Variability Index (dPVi) for Intradialytic Hypotension

  From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).

• Correlation Between PVI, dPVi, %PVi and Changes in Blood Pressure

  Pre-dialysis (baseline) and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).

Study Arms (1)

Maintenance Hemodialysis Patients

Adult patients aged 18 to 80 years who have been receiving maintenance hemodialysis for more than 3 months. All participants will be monitored for blood pressure and Pleth Variability Index (PVI) measurements before and during hemodialysis sessions. The occurrence of intradialytic hypotension and its association with PVI will be evaluated.

Other: Non-invasive Monitoring

Interventions

Non-invasive Monitoring OTHER

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.

Maintenance Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• Wuhu City Second People's Hospital: collaborator
• Wuhu County Traditional Chinese Medicine Hospital: collaborator

Study Sites (1)

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

Wuhu, Anhui, 241000, China

RECRUITING

MeSH Terms

Conditions

Hypotension; Shock; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Qiancheng Xu

CONTACT

86-18297529106; qianchengxu@wnmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 15, 2025
• Study Start: February 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)