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Study Status: Withdrawn
Recruit Status: Withdrawn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