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

Phase 2

Terminated

• Conditions: End Stage Renal Failure, Hemodialysis

• Registration Number: NCT00563342
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-11-22
• Study First Submitted QC: 2007-11-22
• Study First Posted: 2007-11-26
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-07
• Last Update Posted: 2008-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The catheters dysfunction rate	as partial or complete occlusion or infection associated with dialysis catheter

Secondary Outcome Measures

Name	Time	Method
The dialysis quality is also examined (urea reduction rate, total ultrafiltration)	as partial or complete occlusion or infection associated with dialysis catheter

Trial Locations

Locations (1)

Lacarin; 🇫🇷 Clermont-Ferrand, France