Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution
NCT ID: NCT02577718
Last Updated: 2017-11-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2015-11-30
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution.
* The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nitroglycerin-Citrate-Ethanol (NiCE)
Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed
Nitroglycerin-citrate-ethanol (NiCE)
Lock solution instilled in catheter lumens for 2 hours then flushed. Administration for up to 30 days, daily as in-patient or once weekly as out-patient
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nitroglycerin-citrate-ethanol (NiCE)
Lock solution instilled in catheter lumens for 2 hours then flushed. Administration for up to 30 days, daily as in-patient or once weekly as out-patient
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Novel Anti-Infective Technologies, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chaftari AM, Hachem R, Szvalb A, Taremi M, Granwehr B, Viola GM, Amin S, Assaf A, Numan Y, Shah P, Gasitashvili K, Natividad E, Jiang Y, Slack R, Reitzel R, Rosenblatt J, Mouhayar E, Raad I. A Novel Nonantibiotic Nitroglycerin-Based Catheter Lock Solution for Prevention of Intraluminal Central Venous Catheter Infections in Cancer Patients. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00091-17. doi: 10.1128/AAC.00091-17. Print 2017 Jul.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NiCE
Identifier Type: -
Identifier Source: org_study_id