Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

Inclusion Criteria:

- Inpatients who have a long term central venous catheter (CVC)—and the CVC has been in
place for at least 14 days and is expected to remain in place at least for 30 days
after enrollment

- The CVC consists of a 5.0 French size, dual-lumen, peripherally inserted central
catheter

- Patients who are willing and capable to provide Informed Consent

- Patients who are willing and capable to follow the instructions required to complete
the study

- Females (of child bearing potential) and males (of child bearing potential) must be
abstinent or agree to use birth control during the study.

Exclusion Criteria:

- Patients who have an antimicrobial CVC.

- Patients who have a short term CVC that have been placed in ICU (mainly rigid wall
CVCs placed for acute care in ICU).

- Patients who are hypotensive with a systolic blood pressure reading of <110 mmHg at
any time over the 3 days prior to study entry

- Patients who are not awake, not alert, or who cannot express pain or discomfort
related to the catheter locks

- Patients with an existing local or systemic infection as defined by evidence of fever
(a body temperature > 38.0o C with two readings taken at least 10 minutes apart or one
body temperature > 38.3o) and any of the following within 24 hours of enrollment:
Pulse rate > 100 beats/min.; Respiratory rate > 20/min.; WBC count >12,000/mm3,
<4,000/mm3 or differential count showing >10% band forms. Patient will still be
eligible for the study if the participant's white blood cell count (WBC) is outside
normal limits due to chemotherapy treatment or underlying conditions. Systolic blood
pressure <90 mm Hg.

- Signs and symptoms of localized catheter-related infection (tenderness and/or pain,
erythema, swelling, purulent exudates within 2 cm of entry site)

- Patients with an occluded (partially or totally) catheter defined as inability to
either withdraw blood or instill 3cc of fluid without resistance through any catheter
lumen

- Patients with multiple co-existing central venous catheters at the time of enrollment
will not be enrolled.

- Patients in whom the lock solution application will interfere with routine treatment
of the underlying disease

- Patients with a known history of allergic reaction to ethanol, nitroglycerin, or
citrate.

- Female patients who are pregnant or breast feeding

- Patients who are on disulfiram, metronidazole or are dependent on alcohol

- Patients receiving phosphodiesterase type 5 (PDE-5) inhibitors (such as sildenafil,
tadalafil, vardenafil).