Multi-Center, Prospective, Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Safety and Effectiveness of an Antimicrobial Catheter Lock Solution in Maintaining Catheter Patency and Preventing Catheter Related Blood Stream Infections (CRBSI)
- 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter
Patrick Chaftari, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board