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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00614679
First received: February 11, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • catheter salvage [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00614679

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

Locations
United States, Texas
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Sub-Investigator: Barbara Trautmer, MD, PhD         
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Saima Aslam, MD    713-791-1414 ext 5546    saslam@bcm.tmc.edu   
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

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional 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
Study First Received: February 11, 2008
Last Updated: February 11, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014