NEWS HIGHLIGHTS
Published Studies Related to Inomax (Nitric Oxide Inhalation)
Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. [2011.09.10]
BACKGROUND: Asthma exacerbations during pregnancy are common and can be associated with substantial maternal and fetal morbidity. Treatment decisions based on sputum eosinophil counts reduce exacerbations in non-pregnant women with asthma, but results with the fraction of exhaled nitric oxide (F(E)NO) to guide management are equivocal. We tested the hypothesis that a management algorithm for asthma in pregnancy based on F(E)NO and symptoms would reduce asthma exacerbations... INTERPRETATION: Asthma exacerbations during pregnancy can be significantly reduced with a validated F(E)NO-based treatment algorithm. FUNDING: National Health and Medical Research Council of Australia. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Inhaled nitric oxide after left ventricular assist device implantation: a prospective, randomized, double-blind, multicenter, placebo-controlled trial. [2011.08]
BACKGROUND: Used frequently for right ventricular dysfunction (RVD), the clinical benefit of inhaled nitric oxide (iNO) is still unclear. We conducted a randomized, double-blind, controlled trial to determine the effect of iNO on post-operative outcomes in the setting of left ventricular assist device (LVAD) placement... CONCLUSIONS: Use of iNO at 40 ppm in the perioperative phase of LVAD implantation did not achieve significance for the primary end point of reduction in RVD. Similarly, secondary end points of time on mechanical ventilation, hospital or intensive care unit stay, and the need for RVAD support after LVAD placement were not significantly improved. Copyright (c) 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
Inhaled nitric oxide for the adjunctive therapy of severe malaria: protocol for a randomized controlled trial. [2011.07.13]
BACKGROUND: Severe malaria remains a major cause of global morbidity and mortality... DISCUSSION: Noteworthy aspects of this trial design include its efficient sample size supported by a computer simulation study to evaluate statistical power, meticulous attention to complex ethical issues in a cross-cultural setting, and innovative strategies for safety monitoring and blinding to treatment allocation in a resource-constrained setting in sub-Saharan Africa.
Comparison of inhaled nitric oxide with aerosolized iloprost for treatment of pulmonary hypertension in children after cardiopulmonary bypass surgery. [2011.07]
OBJECTIVES: Pilot study to compare the effect of inhaled nitric oxide (iNO) and aerosolized iloprost in preventing perioperative pulmonary hypertensive crises (PHTCs). BACKGROUND: Guidelines recommend the use of iNO to treat PHTCs, but treatment with iNO is not an ideal vasodilator. Aerosolized iloprost may be a possible alternative to iNO in this setting... CONCLUSIONS: In this pilot study, aerosolized iloprost had a favorable safety profile. Larger trials are needed to compare its efficacy to iNO for the treatment of perioperative pulmonary hypertension. However, neither treatment alone abolished the occurrence of PHTCs.
Comparison of inhaled nitric oxide versus oxygen on hemodynamics in patients with mitral stenosis and severe pulmonary hypertension after mitral valve surgery. [2011.04.01]
Pulmonary hypertension represents an important cause of morbidity and mortality in patients with mitral stenosis who undergo cardiac surgery, especially in the postoperative period. The aim of this study was to test the hypothesis that inhaled nitric oxide (iNO) would improve the hemodynamic effects and short-term clinical outcomes of patients with mitral stenosis and severe pulmonary hypertension who undergo cardiac surgery in a randomized, controlled study...
Clinical Trials Related to Inomax (Nitric Oxide Inhalation)
Comparison of Inhaled Nitric Oxide Versus Oxygen in Patient Reactivity During Acute Pulmonary Vasodilator Testing [Completed]
A minimum of 100 patients will be enrolled in the study to demonstrate which diagnostic
treatment (oxygen or nitric oxide) is most capable of identifying patients with a reactive
pulmonary vascular bed. Each patient will be given all three treatment regimen, nitric
oxide, oxygen, and the comparison treatment (either nitric oxide or oxygen), with a wash out
period of 10 minutes between each dose. Patients will be randomized at the time of
enrollment to determine which comparison treatment they will receive.
Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children [Recruiting]
Acute chest syndrome is a severe sickle cell disease complication in children requiring
blood transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a
potent vasodilator that could reverse pulmonary vascular occlusion and restore normal
oxygenation. The randomized trial will test that hypothesis.
Effect of Nitric Oxide (N.O.) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation [Recruiting]
In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide
to prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended
donor criteria liver grafts based on changes in proteomic and metabolomic markers following
revascularization of the donor graft.
In reviewing the literature, no uniform extended criteria donor classification exists. The
characteristics most associated with liver graft failure appear to be cold ischemia time
greater than 10 hours, warm ischemia time greater than 40 minutes, donor age > 55 years of
age, donor hospitalization > 5 days, a donation after cardiac death (DCD) graft, and a split
graft. The researchers will exclude warm ischemia time as this is impossible to predict
prior to the transplantation. Any donor meeting at least one of the other criteria will be
classified as an ECD donor.
Hypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after
EDC liver transplantation
- Suppression of oxidative injury will improve graft function postoperatively as measured
by INR, bilirubin, transaminases, and duration of hospital stay.
Hypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on
reduction in post-reperfusion oxidative injury as readily measured by the detectable changes
in the protein and metabolic profiles in plasma of patients treated with inhaled-NO
- NMR (nuclear magnetic resonance)-based metabolic markers (xanthine end-products,
lactate, and hepatic osmolytes) that are consistent with acute liver injury will be
decreased in NO-treated recipients.
- Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen
sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated
with inhaled-NO
- Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial
peroxiredoxins isoforms and the number that are oxidized in NO-treated liver
recipients.
Phase II Evaluation of Exhaled Nitric Oxide (NO) [Recruiting]
Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis [Recruiting]
The purpose of this study is to determine whether inhaled nitric oxide is an effective
treatment for microcirculatory dysfunction and acute organ system failure in the early stage
of sepsis therapy.
Reports of Suspected Inomax (Nitric Oxide Inhalation) Side Effects
Oxygen Saturation Decreased (17),
Cardio-Respiratory Arrest (9),
Device Failure (8),
OFF Label USE (5),
Device Malfunction (4),
Acidosis (3),
Pneumothorax (3),
Blood Pressure Decreased (3),
Pulmonary Hypertension (2),
Patent Ductus Arteriosus (2), more >>
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