Sepsis Clinical Trial
Official title:
A Controlled Prospective Randomized Open-Label Study of Methylene Blue and Inhaled Nitric Oxide in Patients With Septic Shock and Acute Lung Injury
Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in
sepsis the excessive production of NO results in myocardial depression, vasoplegia, and
cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed
study from our group showed advantageous cardiovascular effects of continuously infused
methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another
investigation, we have found that the combination of inhaled NO and continuously infused MB
attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new
study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both
cardiovascular and pulmonary functions as well as clinical outcome in patients with septic
shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic
shock and ALI, will be randomized to groups receiving
1. Conventional treatment (control group)(n =10);
2. MB infusion in addition to conventional treatment (n=10);
3. Inhaled NO in addition to conventional treatment (n=10);
4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment
(n=10).
The therapy with either MB+NO or NO or MB alone will be prolonged for up to 24 h or until resolution of septic shock, whichever occurs first. MB will be injected as a bolus of 2 mg/kg subsequently followed by dose-titrated infusion. The latter beginning with 0.25 mg/kg/h continuing within the range of from 0.05 to 0.5 mg/kg/h. The goal is to maintain mean arterial pressure within the range of 70-90 mm Hg, with the purpose of reducing any concurrent vasopressor therapy. The NO therapy will be started from 10 ppm and aimed at maintaining the mean pulmonary artery pressure at the lowest possible levels by inhaling NO in concentrations from 1 to 20 ppm. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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