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

NCT ID: NCT01483872

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-09-30

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.

Conditions

Infection; Dialysis Catheter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NAC/Tigecycline/Heparin combination lock solution

A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter

Group Type: EXPERIMENTAL

NAC/Tigecycline/Heparin combination lock solution

Intervention Type: DRUG

Standard anticoagulant (heparin or citrate)

Standard anticoagulant (heparin or citrate)

Group Type: PLACEBO_COMPARATOR

Standard anticoagulant (Heparin or Citrate)

Intervention Type: DRUG

Interventions

NAC/Tigecycline/Heparin combination lock solution

Intervention Type: DRUG

Standard anticoagulant (Heparin or Citrate)

Intervention Type: DRUG

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Saima Aslam

Asst Adjunct Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCSD Medical Center

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35363884 (View on PubMed)

Other Identifiers

101094

Identifier Type: -

Identifier Source: org_study_id