Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
2 other identifiers
interventional
19
1 country
1
Brief Summary
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2009
CompletedFirst Posted
Study publicly available on registry
April 1, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
July 16, 2013
CompletedMay 21, 2020
May 1, 2020
7 months
March 31, 2009
January 26, 2013
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Plasma Nitrite Concentration (Micromol/L)
Samples for pharmacokinetic analysis were collected from subjects treated with sodium nitrite at -15, -5, 0, 10, 30, 60, and 90 minutes after starting nitrite infusion and then at 2, 4, 6, 8, 12, 24, and every 24 hours after starting nitrite infusion. The sample at the time of starting the infusion was considered to be the time 0 sample. On study day 14 additional blood samples were collected at 0, 10, 30, 60, and 90 minutes and at 2, 4, 6, 8, and 12 hours after stopping nitrite infusion. Blood samples were analyzed for nitrite levels using mass spectroscopy.
multiple time points up to the end of day 14
Secondary Outcomes (2)
Safety of a 14 Day Infusion of Sodium Nitrite
14 days
Efficacy of 14 Day Infusion of Sodium Nitrite
14 days
Study Arms (2)
Nitrite
EXPERIMENTALContinuous intravenous infusion of Sodium Nitrite
Vehicle control
PLACEBO COMPARATORContinuous intravenous infusion of saline
Interventions
14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
14 day continuous infusion of a vehicle control infusion
Eligibility Criteria
You may qualify if:
- Ruptured cerebral aneurysm
You may not qualify if:
- Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Health System Medical Center
Charlottesville, Virginia, 22903, United States
Related Publications (1)
Oldfield EH, Loomba JJ, Monteith SJ, Crowley RW, Medel R, Gress DR, Kassell NF, Dumont AS, Sherman C. Safety and pharmacokinetics of sodium nitrite in patients with subarachnoid hemorrhage: a phase IIa study. J Neurosurg. 2013 Sep;119(3):634-41. doi: 10.3171/2013.3.JNS13266. Epub 2013 May 24.
PMID: 23706046DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Edward Oldfield
- Organization
- University of Virginia Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Oldfield, MD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2009
First Posted
April 1, 2009
Study Start
April 1, 2010
Primary Completion
November 1, 2010
Study Completion
August 1, 2012
Last Updated
May 21, 2020
Results First Posted
July 16, 2013
Record last verified: 2020-05