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

Primary Purpose

End Stage Renal Failure, Hemodialysis

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ethanol
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure, Hemodialysis focused on measuring Ethanol, lock solution, infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lacarin

Outcomes

Primary Outcome Measures

The catheters dysfunction rate

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2007
Last Updated
October 7, 2008
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT00563342
Brief Title
Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients
Acronym
Ethanol
Official Title
Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure, Hemodialysis
Keywords
Ethanol, lock solution, infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
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
Primary Outcome Measure Information:
Title
The catheters dysfunction rate
Time Frame
as partial or complete occlusion or infection associated with dialysis catheter
Secondary Outcome Measure Information:
Title
The dialysis quality is also examined (urea reduction rate, total ultrafiltration)
Time Frame
as partial or complete occlusion or infection associated with dialysis catheter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Souweine, Pr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lacarin
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27473868
Citation
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.
Results Reference
derived

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

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