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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00563342

Acronym

Ethanol

Enrollment

Registered

2007-11-26

Start date

2007-06-30

Completion date

2008-03-31

Last updated

2008-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Failure, Hemodialysis

Keywords

Ethanol, lock solution, infection

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)

Interventions

DRUGEthanol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The catheters dysfunction rate	as partial or complete occlusion or infection associated with dialysis catheter

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026