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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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End Stage Renal Failure, Hemodialysis

Keywords

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Ethanol, lock solution, infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Bertrand Souweine, Pr

Role: PRINCIPAL_INVESTIGATOR

Locations

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Lacarin

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Coupez E, Timsit JF, Ruckly S, Schwebel C, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Darmon M, Boyer A, Azoulay E, Bouadma L, Lautrette A, Souweine B. Guidewire exchange vs new site placement for temporary dialysis catheter insertion in ICU patients: is there a greater risk of colonization or dysfunction? Crit Care. 2016 Jul 30;20(1):230. doi: 10.1186/s13054-016-1402-6.

Reference Type DERIVED

PMID: 27473868 (View on PubMed)

Other Identifiers

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CHU-0027

Identifier Type: -

Identifier Source: org_study_id