CompletedNot Applicable

Prediction of Risk of Hypotension in Hemodialysis

France60 participantsStarted 2015-01-01

Plain-language summary

The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.

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: * 18 years old minimum patients * Patients with chronic end-stage renal failure * Patients treated with hemodialysis for at least 3 months, 3 times a week (duration of sessions 3 to 5 hours) * Patients with at least 2 episodes of intradialytic hypotension in the last month * Patients without acute events within 3 months prior to inclusion * Patients affiliated with or receiving social security benefits Exclusion Criteria: * Hemoglobin levels outside the limits of measurement (\<7 g/L or \>15g/L) * Patients whose probable survival does not exceed 6 months * Patients with progressive acute pathology * Patient following another research protocol that may influence results * Patients with psychiatric pathology or cognitive impairments that make them unable to give informed consent

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

Risk of PAS with symptom

Timeframe: at 3 week

Trial details

NCT IDNCT03350308

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-27

View on ClinicalTrials.gov More Chronical Kidney Disease trials