NCT07022847 Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis
| NCT ID | NCT07022847 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wannan Medical College |
| Condition | Hypotension and Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-02-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07022847 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypotension and Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07022847 currently recruiting?
Yes, NCT07022847 is actively recruiting participants. Contact the research team at qianchengxu@wnmc.edu.cn for enrollment information.
Where is the NCT07022847 trial being conducted?
This trial is being conducted at Wuhu, China.
Who is sponsoring the NCT07022847 clinical trial?
NCT07022847 is sponsored by First Affiliated Hospital of Wannan Medical College. The trial plans to enroll 200 participants.