Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT01101412
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 Description:
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.
Study:
NCT01101412
Study Brief:
Protocol Section:
NCT01101412