Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome
Status:
Terminated
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
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).