Back to resultsUse of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
Primary Purpose
Infection; Dialysis Catheter
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NAC/Tigecycline/Heparin combination lock solution
Standard anticoagulant (Heparin or Citrate)
Sponsored by
About this trial
This is an interventional treatment trial for Infection; Dialysis Catheter focused on measuring salvage infected hemodialysis catheters, novel catheter lock solution
Eligibility Criteria
Inclusion Criteria:
- Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter and expected to continue hemodialysis for 3 months will be eligible for enrollment.
Exclusion Criteria:
The following patients will be excluded from study entry:
- patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and
- patient is allergic to NAC, tigecycline, minocycline, or heparin.
The following patients will be excluded from randomization:
- patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors,
- patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema,
- patient is pregnant or will become pregnant,
- the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.
Sites / Locations
- UCSD Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NAC/Tigecycline/Heparin combination lock solution
Standard anticoagulant (heparin or citrate)
Arm Description
A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter
Standard anticoagulant (heparin or citrate)
Outcomes
Primary Outcome Measures
Success Rate
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Secondary Outcome Measures
Full Information
NCT ID
NCT01483872
First Posted
November 26, 2011
Last Updated
August 15, 2019
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01483872
Brief Title
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
Official Title
Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to poor enrollment.
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy.
The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection; Dialysis Catheter
Keywords
salvage infected hemodialysis catheters, novel catheter lock solution
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAC/Tigecycline/Heparin combination lock solution
Arm Type
Experimental
Arm Description
A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter
Arm Title
Standard anticoagulant (heparin or citrate)
Arm Type
Placebo Comparator
Arm Description
Standard anticoagulant (heparin or citrate)
Intervention Type
Drug
Intervention Name(s)
NAC/Tigecycline/Heparin combination lock solution
Intervention Type
Drug
Intervention Name(s)
Standard anticoagulant (Heparin or Citrate)
Primary Outcome Measure Information:
Title
Success Rate
Description
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter and expected to continue hemodialysis for 3 months will be eligible for enrollment.
Exclusion Criteria:
The following patients will be excluded from study entry:
patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and
patient is allergic to NAC, tigecycline, minocycline, or heparin.
The following patients will be excluded from randomization:
patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors,
patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema,
patient is pregnant or will become pregnant,
the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35363884
Citation
Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
Results Reference
derived
Learn more about this trial
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
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