Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies

RATIONALE: Antimicrobial solution comprising trimethoprim-sulfamethoxazole, edetate calcium disodium, and ethanol may help prevent blockages and infections from forming in patients with central venous access catheters or peripheral venous catheters.

PURPOSE: This randomized trial is studying an antimicrobial solution or saline solution in maintaining catheter patency and preventing catheter-related blood infections in patients with malignancies.

OBJECTIVES:

* To evaluate the safety of antimicrobial catheter lock solution comprising trimethoprim-sulfamethoxazole, edetate calcium disodium (EDTA), and ethanol versus saline solution in patients with malignancies.
* To compare the efficacy of this lock solution versus saline solution in maintaining catheter patency in these patients.
* To demonstrate the superiority of this lock solution in preventing or reducing the incidence of catheter-related bloodstream infections in patients with long-term indwelling catheters.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical site and randomized to 1 of 2 intervention arms.

* Arm I: Patients receive antimicrobial solution into the central or peripheral venous catheter (CVC or PVC) once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.
* Arm II: Patients receive saline solution into the CVC or PVC once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.

After completion of study, patients are followed up at 10 days.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a malignancy
* Indwelling catheter (central or peripheral) with external lumen(s) that has been in place for ≤ 7 days

  * Inpatients must have each lumen of the catheter able to be locked with the study solution uninterruptedly for a minimum of one hour per day
  * Outpatients must agree to flush and relock the catheter each day

PATIENT CHARACTERISTICS:

* Willing and able to follow the instructions required to complete the study
* No local or systemic infection as defined by the evidence of fever (e.g., body temperature ≥ 38.0 degrees C) within 24 hours including any of the following:

  * White Blood Count (WBC) ≥ 12,000/mm³ or ≤ 4,000/mm³ OR with a differential count showing ≥ 10% bands
  * Tachycardia defined as pulse rate ≥ 100 bpm
  * Tachypnea defined as respiratory rate \> 20 breaths/minute
  * Hypotension defined as systolic blood pressure (BP) ≤ 90 mm Hg
  * Signs and symptoms of localized catheter-related infection (e.g., tenderness and/or pain, erythema, swelling, or purulent exudate within 2 cm of entry site)
* No occluded (partially or totally) catheter defined as inability to either withdraw blood or instill 3 cc of fluid without resistance through any catheter lumen
* No known alcohol dehydrogenase deficiency
* No known history of allergic reaction to ethanol, trimethoprim (including trimethoprim/sulfamethoxazole), or any other components within the lock solution formulation
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No renal failure or creatinine level ≥ 2.0 mg/dL
* No known heart failure or ejection fraction ≤ 25%
* No alcohol dependency

PRIOR CONCURRENT THERAPY:

* Concurrent investigational chemotherapy agents allowed

  * No concurrent non-chemotherapy investigational protocols
* Not requiring multiple central venous catheters

  * Multiple lumens in a single catheter allowed
* No catheter coated or impregnated with heparin or antimicrobial or antiseptic agent
* No concurrent routine treatment of the underlying disease that will interfere with the lock solution
* No concurrent disulfiram or metronidazole