Trial Outcomes & Findings for Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution (NCT NCT02577718)

NCT ID: NCT02577718

Last Updated: 2017-11-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	NiCE Lock
Overall Study STARTED	60
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	NiCE Lock
Overall Study Death	6
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

Baseline characteristics by cohort

Measure	NiCE Lock n=60 Participants
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	60 Participants n=5 Participants
Number of patients with Hypertension	36 Participants n=5 Participants
Type of Cancer Acute Lymphatic Leukemia	12 Participants n=5 Participants
Type of Cancer Acute Monocytic Leukemia	34 Participants n=5 Participants
Type of Cancer Lymphoma	1 Participants n=5 Participants
Type of Cancer Aplastic Anemia	1 Participants n=5 Participants
Type of Cancer Myelofibrosis	1 Participants n=5 Participants
Type of Cancer Chronic Lymphatic Leukemia	1 Participants n=5 Participants
Type of Cancer Chronic Monocytic Leukemia	3 Participants n=5 Participants
Type of Cancer Acute Myelogenous Leukemia	2 Participants n=5 Participants
Type of Cancer Myelodysplastic Syndrome	3 Participants n=5 Participants
Type of Cancer B cell Acute Lymphatic Leukemia	1 Participants n=5 Participants
Type of Cancer Biphenotypic acute leukemia	1 Participants n=5 Participants
Median Standard Deviation of Systolic Blood Pressure	7.86 mm Hg n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days

Population: All patients receiving at least one dose

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.

Outcome measures

Measure	NiCE Lock n=60 Participants All patients who received at least one dose	Off NiCE Lock Days patients did not receive NiCE Lock
Number of Participants With Drug-Related Hypotension	0 Participants	—

SECONDARY outcome

Timeframe: 60 Days

Population: 619 catheter days on NiCE Lock Solution / 1853 catheter days off NiCE Lock Solution

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

Outcome measures

Measure	NiCE Lock n=619 catheter days All patients who received at least one dose	Off NiCE Lock n=1853 catheter days Days patients did not receive NiCE Lock
Incidence of Catheter-Associated Infections	0 infections per 1000 catheter days	1.6 infections per 1000 catheter days

Adverse Events

NiCE Lock

Serious events: 0 serious events

Other events: 2 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	NiCE Lock n=60 participants at risk 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.
Skin and subcutaneous tissue disorders Rash	1.7% 1/60 • Number of events 1
Nervous system disorders Headache (transient)	1.7% 1/60 • Number of events 1

Additional Information

Dr. A M Chaftari

MD Anderson Cancer Center

Phone: 7137923491

Email: achaftar@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place