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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Anti-Infective Agents; Calcium; Calcium, Dietary; Edetic Acid; Ethanol; Pentetic Acid; Pharmaceutical Solutions; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

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