Clinical Trial: Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
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.
Sponsor: M.D. Anderson Cancer Center
Current Primary Outcome:
- Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter [ Time Frame: 60 days ]
- Time to development of a catheter-related bloodstream infections during the period of lock therapy administration [ Time Frame: 60 days ]
- Adverse events [ Time Frame: 60 days ]
Original Primary Outcome:
- Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter
- Time to development of a CRBSI during the period of lock therapy administration
- Adverse events
Current Secondary Outcome:
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: April 9, 2010
Date Started:
Date Completion:
Last Updated: February 13, 2013
Last Verified: February 2013