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 range18 Years

SexALL

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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

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