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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563342
First Posted: November 26, 2007
Last Update Posted: October 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Clermont-Ferrand
  Purpose

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)


Condition Intervention Phase
End Stage Renal Failure, Hemodialysis Drug: Ethanol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • The catheters dysfunction rate [ Time Frame: as partial or complete occlusion or infection associated with dialysis catheter ]

Secondary Outcome Measures:
  • The dialysis quality is also examined (urea reduction rate, total ultrafiltration) [ Time Frame: as partial or complete occlusion or infection associated with dialysis catheter ]

Estimated Enrollment: 40
Study Start Date: June 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563342


Locations
France
Lacarin
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Bertrand Souweine, Pr
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bertrand Souweine, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00563342     History of Changes
Other Study ID Numbers: CHU-0027
First Submitted: November 22, 2007
First Posted: November 26, 2007
Last Update Posted: October 8, 2008
Last Verified: October 2008

Keywords provided by University Hospital, Clermont-Ferrand:
Ethanol, lock solution, infection

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Pharmaceutical Solutions
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs