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

This study is currently recruiting participants.

Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), February 2008

Sponsored by:	Baylor College of Medicine
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00614679

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 I

MedlinePlus related topics: Antibiotics Blood Thinners Dialysis Kidney Failure

Drug Information available for: Heparin Tigecycline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia

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
1: Experimental 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

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

Publications indexed to this study:

Aslam S, Trautner BW, Ramanathan V, Darouiche RO. Pilot trial of N-acetylcysteine and tigecycline as a catheter-lock solution for treatment of hemodialysis catheter-associated bacteremia. Infect Control Hosp Epidemiol. 2008 Sep;29(9):894-7.

Responsible Party:	Baylor College of Medicine ( Rabih Darouiche )
Study ID Numbers:	H-17624
Study First Received:	February 11, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00614679
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

Study placed in the following topic categories:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Renal Insufficiency
Tigecycline
Kidney Failure, Chronic
Bacteremia
Inflammation

Calcium heparin
Sepsis
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Heparin
Kidney Failure

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009