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

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

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.

Study Overview

• Status: Terminated
• Conditions: Infection; Dialysis Catheter
• Intervention / Treatment: Drug: NAC/Tigecycline/Heparin combination lock solution; Drug: Standard anticoagulant (Heparin or Citrate)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: NAC/Tigecycline/Heparin combination lock solution
Placebo Comparator: Standard anticoagulant (heparin or citrate)	Drug: Standard anticoagulant (Heparin or Citrate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	Nine participants signed consent forms, only one randomized. Data was not analyzed.	90 days

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: November 26, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: salvage infected hemodialysis catheters; novel catheter lock solution
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Heparin; Calcium heparin; Tigecycline; Anticoagulants
• Other Study ID Numbers: 101094