Jan 21, 2011

Safety and feasibility of long-term intravenous sodium nitrite infusion in healthy volunteers

PloS One
Ryszard M PlutaRussell R Lonser

Abstract

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. 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. 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 ...Continue Reading

  • References49
  • Citations49

References

  • References49
  • Citations49

Citations

Mentioned in this Paper

Metabolic Process, Cellular
Arterial Pulse Pressure
Ischemia
Sodium Nitroprusside
Blood - Brain Barrier Anatomy
Sulfanilamide
Creatinine
Sulfanilamide, anti infective agent used to treat candida albicans, Homeopathic preparation
Arterial System
Deoxyhemoglobin

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