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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01101412

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Edetate Calcium Disodium Drug: Ethanol Drug: Trimethoprim-sulfamethoxazole Other: Hypertonic Saline	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

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 Preventing Catheter Related Blood Stream Infections (CRBSI)

Arms and Interventions

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.	Drug: Edetate Calcium Disodium Given through CVC or PVC. Other Names: Calcium Disodium Versenate Calcium EDTA Drug: Ethanol Given through CVC or PVC Other Names: Ethyl Alcohol Ehtyol Ethamolin Drug: Trimethoprim-sulfamethoxazole Given through CVC or PVC Other Names: Bactrim Trimethoprim sulfamethoxazole Bactrim DS Cotrim DS Septra Sulfatrim DS Trisulfam Uroplus DS Uroplus SS Co-trimoxazole SMX-TMP TMP-SMX
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.	Other: Hypertonic Saline Given through CVC or PVC Other Names: Saline Saline Solution

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.

Drug: Edetate Calcium Disodium

Given through CVC or PVC.

Other Names:

Calcium Disodium Versenate

Calcium EDTA

Drug: Ethanol

Given through CVC or PVC

Other Names:

Ethyl Alcohol

Ehtyol

Ethamolin

Drug: Trimethoprim-sulfamethoxazole

Given through CVC or PVC

Other Names:

Bactrim

Trimethoprim

sulfamethoxazole

Bactrim DS

Cotrim DS

Septra

Sulfatrim DS

Trisulfam

Uroplus DS

Uroplus SS

Co-trimoxazole

SMX-TMP

TMP-SMX

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.

Other: Hypertonic Saline

Given through CVC or PVC

Other Names:

Saline

Saline Solution

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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