CompletedNot Applicable

Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration

Netherlands20 participantsStarted 2011-10

Plain-language summary

Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains high. This may at least be partly due to the insufficient removal of (especially protein-bound) uremic toxins which have been associated with cardiovascular morbidity and mortality. It is unknown whether the combination of long-hour haemodialysis (HD) with convection increases the removal of these toxins. Long-hour HD and long-hour haemodiafiltration (HDF) may also improve haemodynamic stability which is an important factor in treatment quality. The investigators aim to study the removal of uremic toxins in long-hour HD and HDF and to compare the haemodynamics between 4-hour and 8-hour HD and HDF. Objectives: The primary aim is to study the removal of (especially protein-bound) uremic toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic response between 4-hour and 8-hour HD and HDF.

Who can participate

Age range

18 Years – 80 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: * prevalent conventional HD patients * AV-fistula enabling double-needle vascular access with blood flow rate of at least 350 ml/min * informed consent * age more than 18 years Exclusion Criteria: * withdrawal of consent * acute intercurrent illness (infection, malignancy, cardiovascular event, uncontrolled diabetes)

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

removal of uremic toxins

Timeframe: before dialysis and at 15,30,60,120,240 minutes (4-hour and 8-hour sessions) and at 360 and 480 minutes (8-hour sessions)

Trial details

NCT IDNCT01328119

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-01

View on ClinicalTrials.gov More Uremic Toxins trials