Evidence map›Paper›PMID 18671702›Full record

Trial reportBritish journal of haematology2008

Sodium nitrite promotes regional blood flow in patients with sickle cell disease: a phase I/II study.

A Kyle Mack, Vicki R McGowan Ii, Carole K Tremonti, Diana Ackah, Christopher Barnett, Roberto F Machado, Mark T Gladwin, Gregory J Kato

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in British journal of haematology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01033227 (A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Treatment of Vaso-Occlusive Crisis Associated With Sickle Cell Disease), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01033227 phase1 / phase2terminatednot on this mapstarted 2009, after this paper: background citation

A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Treatment of Vaso-Occlusive Crisis Associated With Sickle Cell Disease

TypeinterventionalSponsorChildren's Hospital Los AngelesRan2009 to 2012Enrolled5ConditionsSickle Cell DiseaseArmssodium nitrite injection, usp
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 63 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. cGMP modulation therapeutics for sickle cell disease.Experimental biology and medicine (Maywood, N.J.) · 2019
    Review
  6. Review
  7. Article
  8. Role of blood and vascular smooth muscle in the vasoactivity of nitrite.American journal of physiology. Heart and circulatory physiology · 2014
    Article
  9. Article
  10. Article
  11. Inorganic nitrite supplementation for healthy arterial aging.Journal of applied physiology (Bethesda, Md. : 1985) · 2014
    Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Inhibition of phosphodiesterase 9A reduces cytokine-stimulated in vitro adhesion of neutrophils from sickle cell anemia individuals.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2011
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

A Kyle MackPulmonary and Vascular Medicine Branch, National Heart, Lung and Blood Institute; National Institutes of Health, Bethesda, MD, USA.
Vicki R McGowan Ii
Carole K Tremonti
Diana Ackah
Christopher Barnett
Roberto F Machado
Mark T Gladwin
Gregory J Kato
National Institutes of Health · USNational Institutes of Health Clinical Center · USNational Heart Lung and Blood Institute · US

Funding

Therapeutic Application of Intravascular Nitrite for Sickle Cell DiseaseZIAHL006024 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI KATO, GREGORY · 2009 to 2014
$544k
Therapeutic Application of Intravascular Nitrite for Sickle Cell DiseaseZ01CL008081 · CLC · CLINICAL CENTER · PI KATO, GREGORY J · 2005 to 2008
$0k
Intramural NIH HHS Z01 CL008081Intramural NIH HHS ZIA HL006024
6 · The paper itself

Abstract

In addition to vaso-occlusion by sickled erythrocytes, the pathophysiology of sickle cell disease (SCD) is compounded by the diminished bioavailability of nitric oxide (NO), associated with vasoconstriction, endothelial activation and cell adhesion. We tested the ability of sodium nitrite, which can be converted to NO by deoxyhaemoglobin at acid pH and low oxygen tension, to improve blood flow in patients with SCD. In a phase I/II clinical trial, sodium nitroprusside, NG-monomethyl-L-arginine, and sodium nitrite were infused sequentially into the brachial artery in 14 patients at steady state. In a dose-dependent manner, sodium nitrite infusion rates of 0.4, 4 and 40 micromol/min into the brachial artery augmented mean venous plasma nitrite concentrations (P < 0.0001) and stimulated forearm blood flow up to 77 +/- 11% above baseline (P < 0.0001), measured by venous occlusion strain gauge plethysmography. This nitrite response was blunted significantly compared to controls without SCD, as previously seen with other NO donors. Sodium nitrite infusions were well tolerated without hypotension, clinically significant methaemoglobinaemia or other untoward events. The unique pharmacological properties of nitrite as a hypoxia-potentiated vasodilator and cytoprotective agent in the setting of ischaemia-reperfusion injury make this anion a plausible NO donor for future clinical trials in SCD.

Indexed as

AdultAnemia, Sickle CellDose-Response Relationship, DrugForearmHumansMiddle AgedNitric Oxide DonorsNitroprussideRegional Blood FlowSodium NitriteVasodilationVasodilator AgentsYoung AdultNitric Oxide DonorsNitroprussideSodium NitriteVasodilator Agents

Identifiers

PMID18671702
PMCPMC2766260
OpenAlexW2013752873

What OpenQuestion holds

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Read underepoch 390

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.