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

University Hospital, Clermont-Ferrand

Status and phase: Terminated; Phase 2

Conditions: End Stage Renal Failure, Hemodialysis

Treatments: Drug: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT00563342

CHU-0027

Details and patient eligibility

About

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)

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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