Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections

Infection; Dialysis Catheter Clinical Trial

Official title:

Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01483872
• Other study ID #: 101094
• Status: Terminated
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

1. patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and

2. patient is allergic to NAC, tigecycline, minocycline, or heparin.

The following patients will be excluded from randomization:

1. patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors,

2. patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema,

3. patient is pregnant or will become pregnant,

4. the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.

Related Conditions & MeSH terms

• Infection
• Infection; Dialysis Catheter

Intervention

Drug:
• NAC/Tigecycline/Heparin combination lock solution

• Standard anticoagulant (Heparin or Citrate)

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	Nine participants signed consent forms, only one randomized. Data was not analyzed.	90 days