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A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614679
First Posted: February 13, 2008
Last Update Posted: February 13, 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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.

Condition Intervention Phase
End-Stage Renal Disease Hemodialysis Catheter-Associated Infection Drug: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Treatment success within 90 days [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • catheter salvage [ Time Frame: 90 days ]

Estimated Enrollment: 20
Study Start Date: October 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
single arm trial of experimental catheter lock solution
Drug: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin
N-acetylcystein 80 mg/ml, tigecycline 1 mg/ml, and heparin 2000 units/ml. This will be a 5 ml catheter lock solution

  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:

  • Adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures.

Exclusion Criteria:

  • Patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to NAC or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.
  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): NCT00614679


Contacts
Contact: Saima Aslam, MD 713-791-1414 ext 5546 saslam@bcm.tmc.edu

Locations
United States, Texas
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Saima Aslam, MD    713-791-1414 ext 5546    saslam@bcm.tmc.edu   
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Sub-Investigator: Barbara Trautmer, MD, PhD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Venkat Ramanathan, MD    713-798-8350    ramanath@bcm.tmc.edu   
Sponsors and Collaborators
Baylor College of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rabih Darouiche, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00614679     History of Changes
Other Study ID Numbers: H-17624
First Submitted: February 11, 2008
First Posted: February 13, 2008
Last Update Posted: February 13, 2008
Last Verified: February 2008

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
biofilm
catheter lock solution
catheter salvage

Additional relevant MeSH terms:
Kidney Failure, Chronic
Bacteremia
Catheter-Related Infections
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Pharmaceutical Solutions
Heparin
Tigecycline
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents