A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia
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| ClinicalTrials.gov Identifier: NCT00614679 |
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Recruitment Status :
Completed
First Posted : February 13, 2008
Last Update Posted : October 9, 2019
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Sponsor:
University of California, San Diego
Information provided by (Responsible Party):
Saima Aslam, University of California, San Diego
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Brief Summary:
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 or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 18 participants |
| Allocation: | N/A |
| 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 |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | December 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
single arm trial of experimental catheter lock solution
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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 |
Primary Outcome Measures :
- Treatment success within 90 days [ Time Frame: 90 days ]
Secondary Outcome Measures :
- catheter salvage [ Time Frame: 90 days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| 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.
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
Locations
| United States, Texas | |
| Ben Taub General Hospital | |
| Houston, Texas, United States, 77030 | |
| Michael E. DeBakey VA Medical Center | |
| Houston, Texas, United States, 77030 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
University of California, San Diego
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Saima Aslam, Associate Professor, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00614679 |
| Other Study ID Numbers: |
H-17624 |
| First Posted: | February 13, 2008 Key Record Dates |
| Last Update Posted: | October 9, 2019 |
| Last Verified: | October 2019 |
Keywords provided by Saima Aslam, University of California, San Diego:
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biofilm catheter lock solution catheter salvage |
Additional relevant MeSH terms:
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Bacteremia Catheter-Related Infections Kidney Failure, Chronic Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Renal Insufficiency, Chronic Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes Bacterial Infections |
Bacterial Infections and Mycoses Infections Sepsis Systemic Inflammatory Response Syndrome Inflammation Tigecycline Heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors |