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

NCT ID: NCT01101412

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL

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.

Conditions

Chronic Myeloproliferative Disorders; Infection; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Edetate Calcium Disodium

Intervention Type: DRUG

Given through CVC or PVC.

Ethanol

Intervention Type: DRUG

Given through CVC or PVC

Trimethoprim-sulfamethoxazole

Intervention Type: DRUG

Given through CVC or PVC

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.

Group Type: ACTIVE_COMPARATOR

Hypertonic Saline

Intervention Type: OTHER

Given through CVC or PVC

Interventions

Edetate Calcium Disodium

Given through CVC or PVC.

Intervention Type: DRUG

Ethanol

Given through CVC or PVC

Intervention Type: DRUG

Trimethoprim-sulfamethoxazole

Given through CVC or PVC

Intervention Type: DRUG

Hypertonic Saline

Given through CVC or PVC

Intervention Type: OTHER

Other Intervention Names

Calcium Disodium Versenate; Calcium EDTA; Ethyl Alcohol; Ehtyol; Ethamolin; Bactrim; Trimethoprim; sulfamethoxazole; Bactrim DS; Cotrim DS; Septra; Sulfatrim DS; Trisulfam; Uroplus DS; Uroplus SS; Co-trimoxazole; SMX-TMP; TMP-SMX; Saline; Saline Solution

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Chaftari, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Jorge Cortes, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Official Website

Other Identifiers

MDA-2009-0237

Identifier Type: -

Identifier Source: secondary_id

CDR0000668850

Identifier Type: OTHER

Identifier Source: secondary_id

2009-0237

Identifier Type: -

Identifier Source: org_study_id