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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated bloodstream infection (CLABSI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitroglycerin-Citrate-Ethanol (NiCE) | Experimental | Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin-citrate-ethanol (NiCE) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug-Related Hypotension | Drug-related hypotension is defined as a significant drop in measured blood pressure (BP) that exceeds the normal BP variability of a patient by 30%, that is associated with clinical signs and symptoms (dizziness and syncope) and is unexplained by factors other than the lock solution (such as other antihypertensive drugs, sepsis, bleeding). BP variability will be based on the standard deviation (SD) of a patient's blood pressure measured in the 3 days preceding participation in this trial and will be calculated at the time of trial entry. | From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Catheter-Associated Infections | Catheter-Associated Infections will be measured by microbiological culture defined as either Catheter-Related Bloodstream Infection (CRBSI) as defined by the Infectious Diseases Society of America (IDSA), particularly in neutropenic patients, or Central Line-Associated Bloodstream Infection (CLABSI) as defined by the Centers for Disease Control and Prevention (CDC), particularly in non-neutropenic patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28416559 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NiCE Lock |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | NiCE Lock |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Drug-Related Hypotension | Drug-related hypotension is defined as a significant drop in measured blood pressure (BP) that exceeds the normal BP variability of a patient by 30%, that is associated with clinical signs and symptoms (dizziness and syncope) and is unexplained by factors other than the lock solution (such as other antihypertensive drugs, sepsis, bleeding). BP variability will be based on the standard deviation (SD) of a patient's blood pressure measured in the 3 days preceding participation in this trial and will be calculated at the time of trial entry. | All patients receiving at least one dose | Posted | Count of Participants | Participants | From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NiCE Lock | Patients had days they received NiCE Lock and days they did not receive NiCE Lock (off-Lock days). NiCE Lock was a combination of three different agents so combined results are presented. Most patients received NiCE Lock with Nitroglycerin 30 μg/ml. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient Rash, occurred after 23rd dose, resolved |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. A M Chaftari | MD Anderson Cancer Center | 7137923491 | achaftar@mdanderson.org |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| 60 Days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of patients with Hypertension | Number | Count of Participants | Participants |
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| Type of Cancer | Count of Participants | Participants |
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| Median Standard Deviation of Systolic Blood Pressure | Median | Full Range | mm Hg |
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| Secondary | Incidence of Catheter-Associated Infections | Catheter-Associated Infections will be measured by microbiological culture defined as either Catheter-Related Bloodstream Infection (CRBSI) as defined by the Infectious Diseases Society of America (IDSA), particularly in neutropenic patients, or Central Line-Associated Bloodstream Infection (CLABSI) as defined by the Centers for Disease Control and Prevention (CDC), particularly in non-neutropenic patients | 619 catheter days on NiCE Lock Solution / 1853 catheter days off NiCE Lock Solution | Posted | Number | infections per 1000 catheter days | 60 Days | catheter days | catheter days |
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| 6 |
| 60 |
| 0 |
| 60 |
| 2 |
| 60 |
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| Headache (transient) | Nervous system disorders | Non-systematic Assessment | Mild, Transient Headache reported after 4th of 5 doses, resolved. |
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