CompletedNot Applicable

Epidemiology And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients

China395 participantsStarted 2025-02-15

Plain-language summary

This prospective, multicenter observational study aims to describe how often intradialytic hypotension (IDH) occurs and to identify its risk factors in adult patients receiving maintenance hemodialysis. Intradialytic hypotension is a common complication during dialysis that can lead to symptoms, organ hypoperfusion, and interruption of treatment. Participants will be adults on regular maintenance hemodialysis who meet predefined inclusion and exclusion criteria. Routine clinical information will be collected, including demographics, primary kidney disease, comorbidities, medications, dialysis vintage, dialysis prescription (ultrafiltration volume and rate, dialysate composition, treatment time), and standard laboratory tests. During a defined observation period, blood pressure and related symptoms will be recorded across dialysis sessions to document the frequency, severity, and patterns of IDH. The main goals are to estimate the incidence and prevalence of intradialytic hypotension in maintenance hemodialysis patients and to explore potential risk factors, such as patient characteristics, cardiovascular status, volume status, and dialysis-related parameters. The findings may help clinicians better recognize patients at high risk of IDH and optimize dialysis prescriptions and monitoring strategies to reduce the occurrence of IDH and its adverse consequences.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (≥18 years) with end-stage renal disease on maintenance hemodialysis * Receiving thrice-weekly (or routine) in-center hemodialysis for ≥3 months before enrollment * Scheduled for a standard hemodialysis session of approximately 3-5 hours on the study day * Able to provide informed consent (or via legally authorized representative, if applicable) Exclusion Criteria: * Acute medical instability precluding observation of a routine dialysis session (e.g., active sepsis requiring vasopressors, uncontrolled arrhythmias) * Recent acute coronary syndrome or stroke within 3 months * Pre-dialysis systolic blood pressure \<90 mmHg on the study day before starting dialysis * Ongoing active major bleeding or anticipated urgent transfusion during the session * Pregnancy * Participation in an interventional trial expected to alter intradialytic blood pressure during the observed session

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence Of Intradialytic Hypotension During A Single Maintenance Hemodialysis Session

Timeframe: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).

Trial details

NCT IDNCT07545629

SponsorFirst Affiliated Hospital of Wannan Medical College

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-28

View on ClinicalTrials.gov More Intradialytic Hypotension trials