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Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial.

ABSTRACT: OBJECTIVE:To test the hypothesis that adjunctive inhaled NO would improve RV function and viability in acute PE. METHODS:This was a randomized, placebo-controlled, double blind trial conducted at four academic hospitals. Eligible patients had acute PE without systemic arterial hypotension but had RV dysfunction and a treatment plan of standard anticoagulation. Subjects received either oxygen plus 50?parts per million nitrogen (placebo) or oxygen plus 50?ppm NO for 24?h. The primary composite endpoint required a normal RV on echocardiography and a plasma troponin T concentration <14?pg/mL. The secondary endpoint required a blood brain natriuretic peptide concentration <90?pg/mL and a Borg dyspnea score???2. The sample size of N?=?76 tested if 30% more patients treated with NO would achieve the primary endpoint with 80% power and alpha?=?5%. RESULTS:We randomized 78 patients and after two withdrawals, 38 were treated per protocol in each group. Patients were well matched for baseline conditions. At 24?h, 5/38 (13%) of patients treated with placebo and 9/38 (24%) of patients treated with NO reached the primary endpoint (P?=?0.375). The secondary endpoint was reached in 34% with placebo and 13% of the NO (P?=?0.11). In a pre-planned post-hoc analysis, we examined how many patients with RV hypokinesis or dilation at enrollment resolved these abnormalities; 29% more patients treated with NO resolved both abnormalities at 24?h (P?=?0.010, Cochrane's Q test). CONCLUSIONS:In patients with severe submassive PE, inhaled nitric oxide failed to increase the proportion of patients with a normal troponin and echocardiogram but increased the probability of eliminating RV hypokinesis and dilation on echocardiography. CLINICAL TRIAL REGISTRATION:NCT01939301.

SUBMITTER: Kline JA

PROVIDER: S-EPMC7047892 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial.

Kline Jeffrey A JA Puskarich Michael A MA Jones Alan E AE Mastouri Ronald A RA Hall Cassandra L CL Perkins Anthony A Gundert Emily E EE Lahm Tim T

Nitric oxide : biology and chemistry 20190108

<h4>Objective</h4>To test the hypothesis that adjunctive inhaled NO would improve RV function and viability in acute PE.<h4>Methods</h4>This was a randomized, placebo-controlled, double blind trial conducted at four academic hospitals. Eligible patients had acute PE without systemic arterial hypotension but had RV dysfunction and a treatment plan of standard anticoagulation. Subjects received either oxygen plus 50 parts per million nitrogen (placebo) or oxygen plus 50 ppm NO for 24 h. The primar ...[more]

PMID: 30633959

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Project description:Background: Severe malaria is a leading cause of acquired neurodisability in Africa and is associated with reduced nitric oxide (NO) bioavailability. A neuroprotective role for inhaled NO has been reported in animal studies, and administration of inhaled NO in preterm neonates with respiratory distress syndrome is associated with a 47% reduced risk of cognitive impairment at two years of age.Methods: A randomized double-blind placebo-controlled trial of inhaled NO versus placebo as an adjunctive therapy for severe malaria was conducted in Uganda between 2011 and 2013. Children received study gas for a maximum 72 hours (inhaled NO, 80 parts per million; room air placebo). Neurocognitive testing was performed on children<5 years at 6 month follow-up. The neurocognitive outcomes assessed were overall cognition (a composite of fine motor, visual reception, receptive language, and expressive language), attention, associative memory, and the global executive composite. Main outcomes were attention, associative memory, and overall cognitive ability.Results: Sixty-one children receiving iNO and 59 children receiving placebo were evaluated. Forty-two children (35.0%) were impaired in at least one neurocognitive domain. By intention-to-treat analysis, there were no differences in unadjusted or unadjusted age-adjusted z-scores for overall cognition (? (95% CI): 0.26 (-0.19, 0.72), p = 0.260), attention (0.18 (-0.14, 0.51), p = 0.267), or memory (0.14 (-0.02, 0.30), p = 0.094) between groups by linear regression. Children receiving inhaled NO had a 64% reduced relative risk of fine motor impairment than children receiving placebo (relative risk, 95% CI: 0.36, 0.14-0.96) by log binomial regression following adjustment for anticonvulsant use.Conclusions: Severe malaria is associated with high rates of neurocognitive impairment. Treatment with inhaled NO was associated with reduced risk of fine motor impairment. These results need to be prospectively validated in a larger study powered to assess cognitive outcomes in order to evaluate whether strategies to increase bioavailable NO are neuroprotective in children with severe malaria.Trial registration: ClinicalTrials.gov Identifier: NCT01255215.

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Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial.

Publications

Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial.

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