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

Phase 2TerminatedNCT00563342

University Hospital, Clermont-Ferrand40 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

End Stage Renal Failure, Hemodialysis

Interventions

EthanolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The catheters dysfunction rate

Time frame: as partial or complete occlusion or infection associated with dialysis catheter

Secondary Outcomes

The dialysis quality is also examined (urea reduction rate, total ultrafiltration)