Trial reportPloS one2011
Safety and feasibility of long-term intravenous sodium nitrite infusion in healthy volunteers.
Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the Mechanism of NO Formation and Pharmacokinetics of Long-Term Intravenous Nitrite Infusion in Healthy Volunteers
A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)
Who cites it
45 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Therapeutic potential of nitric oxide and its donors in hemorrhagic and ischemic stroke: a systematic review.Medical gas research · 2026Pooled it
- Beneficial Effect of Sodium Nitrite on EEG Ischaemic Markers in Patients with Subarachnoid Haemorrhage.Translational stroke research · 2022Trial
- Trial
- Inorganic nitrate as a treatment for acute heart failure: a protocol for a single center, randomized, double-blind, placebo-controlled pilot and feasibility study.Journal of translational medicine · 2017Trial
- Effects of sodium nitrite supplementation on vascular function and related small metabolite signatures in middle-aged and older adults.Journal of applied physiology (Bethesda, Md. : 1985) · 2016Trial
- Short-term intravenous sodium nitrite infusion improves cardiac and pulmonary hemodynamics in heart failure patients.Circulation. Heart failure · 2015Trial
- Pharmacokinetics, pharmacodynamics, safety, and tolerability of nebulized sodium nitrite (AIR001) following repeat-dose inhalation in healthy subjects.Clinical pharmacokinetics · 2015Trial
- Radiation sensitization with sodium nitrite in patients with brain metastases: a pilot randomized controlled trial.Medical oncology (Northwood, London, England) · 2015Trial
- Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study.Hypertension (Dallas, Tex. : 1979) · 2015Trial
- Randomized phase 2 trial of intracoronary nitrite during acute myocardial infarction.Circulation research · 2015Trial
- Nitrite therapy is neuroprotective and safe in cardiac arrest survivors.Nitric oxide : biology and chemistry · 2012Trial
- Retrospective cohort analysis of nitrite and nitrate levels in postmortem biological samples after suspected suicide, 2019-24.BMJ public health · 2026Article
- Clinical Pharmacokinetics of Inhaled Drugs for Pulmonary Hypertension.Clinical pharmacokinetics · 2025Review
- The hemodynamic response to nitrite is acute and dependent upon tissue perfusion.Nitric oxide : biology and chemistry · 2024Article
- Rehabilitation in Animal Models of Stroke.Physical therapy research · 2023Review
- Tolerance of Rodents to an Intravenous Bolus Injection of Sodium Nitrate in a High Concentration.Biology · 2022Article
- Endogenous Hemoprotein-Dependent Signaling Pathways of Nitric Oxide and Nitrite.Inorganic chemistry · 2021Review
- Safety and toxicology assessment of sodium nitrite administered by intramuscular injection.Toxicology and applied pharmacology · 2021Article
- Treatment with new organic nitrites in pulmonary hypertension of acute experimental pulmonary embolism.Pharmacology research & perspectives · 2019Article
- Nitrite and nitrate chemical biology and signalling.British journal of pharmacology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundInfusion 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.
findingsThe 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.
conclusionSodium 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.