TerminatedPhase 2

Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients

France40 participantsStarted 2007-06

Plain-language summary

The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis. The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter. As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)

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: * Patients of both genders, over 18 years, * Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days, * Written informed consent * Social security Exclusion Criteria: * Antibiotic therapy during selection phase, * Partial or complete catheter occlusion during selection phase, * Venous pressure at dialysis connection \> 300 mmHg, * Known allergy to ethanol, * Patient involved in any other clinical trial or in the exclusion period * Severe co-morbidity * Acute or chronic infectious disease * Evolutive neoplasia, * HIV, HCV positive serology at inclusion, * Scheduled surgery

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

The catheters dysfunction rate

Timeframe: as partial or complete occlusion or infection associated with dialysis catheter

Trial details

NCT IDNCT00563342

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-03

View on ClinicalTrials.gov More End Stage Renal Failure, Hemodialysis trials