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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Saima Aslam, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01483872
First received: November 26, 2011
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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 particualr 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.


Condition Intervention Phase
Infection; Dialysis Catheter
 Drug: NAC/Tigecycline/Heparin combination lock solution
Drug: Standard anticoagulant (Heparin or Citrate)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Success Rate [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Standard anticoagulant (heparin or citrate)
 Drug: Standard anticoagulant (Heparin or Citrate)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483872

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Saima Aslam, Asst Adjunct Prof, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01483872     History of Changes
Other Study ID Numbers: 101094
Study First Received: November 26, 2011
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
salvage infected hemodialysis catheters
novel catheter lock solution

Additional relevant MeSH terms:
Calcium heparin
Anticoagulants
Citric Acid
Heparin
Tigecycline
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Chelating Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 21, 2013