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

End Stage Renal Failure, Hemodialysis Clinical Trial

— Ethanol  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00563342
• Other study ID #: CHU-0027
• Status: Terminated
• Phase: Phase 2
• First received: November 22, 2007
• Last updated: October 7, 2008
• Start date: June 2007
• Est. completion date: March 2008

Study information

• Verified date: October 2008
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Failure, Hemodialysis
• Kidney Failure, Chronic

Intervention

Drug:
• Ethanol
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

Locations

Country	Name	City	State
France	Lacarin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The catheters dysfunction rate		as partial or complete occlusion or infection associated with dialysis catheter	Yes
Secondary	The dialysis quality is also examined (urea reduction rate, total ultrafiltration)		as partial or complete occlusion or infection associated with dialysis catheter	Yes