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
Recruitment status was Recruiting
Sponsor:
Baylor College of Medicine
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
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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
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 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 May 22, 2013