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

February 13, 2013 updated by: M.D. Anderson Cancer Center

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)

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.

Study Overview

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I: Antimicrobial Solution
Antimicrobial solution into 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.
Given through CVC or PVC.
Other Names:
  • Calcium Disodium Versenate
  • Calcium EDTA
Given through CVC or PVC
Other Names:
  • Ethyl Alcohol
  • Ehtyol
  • Ethamolin
Given through CVC or PVC
Other Names:
  • Co-trimoxazole
  • Bactrim
  • Septra
  • TMP-SMX
  • Bactrim DS
  • Trimethoprim
  • sulfamethoxazole
  • Cotrim DS
  • Sulfatrim DS
  • Trisulfam
  • Uroplus DS
  • Uroplus SS
  • SMX-TMP
Active Comparator: Arm II: Saline Solution
Saline solution into 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.
Given through CVC or PVC
Other Names:
  • Saline
  • Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter
Time Frame: 60 days
60 days
Time to development of a catheter-related bloodstream infections during the period of lock therapy administration
Time Frame: 60 days
60 days
Adverse events
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Patrick Chaftari, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 9, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009-0237
  • MDA-2009-0237
  • CDR0000668850 (Other Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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