Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT01101412
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01101412
Study Brief:
Protocol Section:
NCT01101412