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

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00563342
First received: November 22, 2007
Last updated: October 7, 2008
Last verified: October 2008
  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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563342

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

No publications provided

Responsible Party: Bertrand Souweine, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00563342     History of Changes
Other Study ID Numbers: CHU-0027
Study First Received: November 22, 2007
Last Updated: October 7, 2008
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014