Safety and Feasibility of Long-term Intravenous Sodium Nitrite Infusion in Healthy Volunteers

BACKGROUND: Infusion of sodium nitrite could provide sustained therapeutic concentrations of nitric oxide (NO) for the treatment of a variety of vascular disorders. The study was developed to determine the safety and feasibility of prolonged sodium nitrite infusion. METHODOLOGY: Healthy volunteers, aged 21 to 60 years old, were candidates for the study performed at the National Institutes of Health (NIH; protocol 05-N-0075) between July 2007 and August 2008. All subjects provided written consent to participate. Twelve subjects (5 males, 7 females; mean age, 38.8±9.2 years (range, 21-56 years)) were intravenously infused with increasing doses of sodium nitrite for 48 hours (starting dose at 4.2 µg/kg/hr; maximal dose of 533.8 µg/kg/hr). Clinical, physiologic and laboratory data before, during and after infusion were analyzed. FINDINGS: The maximal tolerated dose for intravenous infusion of sodium nitrite was 267 µg/kg/hr. Dose limiting toxicity occurred at 446 µg/kg/hr. Toxicity included a transient asymptomatic decrease of mean arterial blood pressure (more than 15 mmHg) and/or an asymptomatic increase of methemoglobin level above 5%. Nitrite, nitrate, S-nitrosothiols concentrations in plasma and whole blood increased in all subjects and returned to preinfusion baseline values within 12 hours after cessation of the infusion. The mean half-life of nitrite estimated at maximal tolerated dose was 45.3 minutes for plasma and 51.4 minutes for whole blood. CONCLUSION: Sodium nitrite can be safely infused intravenously at defined concentrations for prolonged intervals. These results should be valuable for developing studies to investigate new NO treatment paradigms for a variety of clinical disorders, including cerebral vasospasm after subarachnoid hemorrhage, and ischemia of the heart, liver, kidney and brain, as well as organ transplants, blood-brain barrier modulation and pulmonary hypertension. CLINICAL TRIAL REGISTRATION INFORMATION: http://www.clinicaltrials.gov; NCT00103025

Inter-Rater Reliability of the California APS Interview for Decisional Abilities (IDA 3.0-CA)

There are few structured methods to assess a client's decisional ability, and none have been evaluated for use by Adult Protective Services (APS) workers. As part of a larger randomized-controlled trial to test the California APS Interview for Decisional Ability (IDA 3.0-CA), we sought to determine the reliability of the instrument. We assessed the extent to which trained APS personnel reached similar conclusions about a client’s decisional ability (i.e., inter-rater reliability) when presented with a client vignette and a completed IDA 3.0-CA form. First, we developed 12 client vignettes based on common client risks. Consideration was given to diversity in gender, race/ethnicity, socioeconomic status, and geography. Second, five content experts familiar with development of the tool reviewed completed IDA 3.0-CA forms for each case. Based on reported case difficulty and level of agreement between experts, eight cases were selected to formally test the instrument’s reliability. Third, 39 APS personnel, who had trained to use the IDA 3.0-CA, reviewed completed IDA 3.0-CA forms and answered questions about the clients’ decisional ability for two randomly-assigned cases. For each case, we calculated the percent correct and inter-rater reliability (Cohen’s Kappa). The percent correct ranged from 67% to 100%, with an average of 87%. The inter-rater reliability for cases ranged from -0.01 to 1.00, with the average across cases of 0.66 (i.e., substantial inter-rater reliability). The results suggest that APS personnel using the IDA 3.0-CA have a high likelihood of reaching similar conclusions about a client’s decisional ability when provided the same client responses.</p

Inter-Rater Reliability of the California APS Interview for Decisional Abilities (IDA 3.0-CA)

There are few structured methods to assess a client's decisional ability, and none have been evaluated for use by Adult Protective Services (APS) workers. As part of a larger randomized-controlled trial to test the California APS Interview for Decisional Ability (IDA 3.0-CA), we sought to determine the reliability of the instrument. We assessed the extent to which trained APS personnel reached similar conclusions about a client’s decisional ability (i.e., inter-rater reliability) when presented with a client vignette and a completed IDA 3.0-CA form. First, we developed 12 client vignettes based on common client risks. Consideration was given to diversity in gender, race/ethnicity, socioeconomic status, and geography. Second, five content experts familiar with development of the tool reviewed completed IDA 3.0-CA forms for each case. Based on reported case difficulty and level of agreement between experts, eight cases were selected to formally test the instrument’s reliability. Third, 39 APS personnel, who had trained to use the IDA 3.0-CA, reviewed completed IDA 3.0-CA forms and answered questions about the clients’ decisional ability for two randomly-assigned cases. For each case, we calculated the percent correct and inter-rater reliability (Cohen’s Kappa). The percent correct ranged from 67% to 100%, with an average of 87%. The inter-rater reliability for cases ranged from -0.01 to 1.00, with the average across cases of 0.66 (i.e., substantial inter-rater reliability). The results suggest that APS personnel using the IDA 3.0-CA have a high likelihood of reaching similar conclusions about a client’s decisional ability when provided the same client responses

Successful Endovascular Therapy of a Penetrating Zone III Jugular Bulb Injury

Penetrating venous injuries via Zone III of the neck extended over jugular bulb are rare. The optimal strategies for these venous injuries are currently unknown because many of the vital structures in this region are poorly accessible to the surgeon and therefore it is difficult to control bleeding. A 76-year-old man got drunk and fell down onto a paper door. The wooden framework of the paper door was broken and got stuck deep in the right side of his neck. Enhanced computed tomography showed the wood stick had penetrated through the right jugular foramen and injured the jugular bulb. We successfully performed right sigmoid and jugular vein occlusion via an endovascular approach using Guglielmi detachable coils at first and then to draw out the wood stick in order to avoid venous bleeding. To our best knowledge, these venous injuries have reported in only four cases. Only one case was performed by endovascular approach using n-butyl cyanoacrylate (NBCA). Coil embolization is much better than NBCA in the light of reducing complications due to adhesion to the inserted wood stick and embolization of unintended vessels. Venous occlusion using coil embolization is the best way to treat a penetrating jugular bulb injury via zone III because of reducing the hemorrhage and air embolism. </jats:p