Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome

What Was Tested

The trial (phase 1) is built around Methylene blue (non-peptide stack partner).

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.

It had four arms (groups): Control (no intervention), MB alone (active comparator), NO alone (active comparator) and MB+NO (active comparator).

The control group with neither nitric oxide nor methylene blue used.

Single methylene blue used.

Nitric oxide alone used.

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed written consent from the patient, or a written consent from a relative together with a the doctor responsible for the treatment of the patient. Aged 18 years or above. Severe sepsis diagnosed less than 72 h prior to randomization. Septic shock defined as a syndrome characterized by severe sepsis in association with either:. A MAP \<70 mm Hg for at least 30 consecutive minutes despite fluid resuscitation or,.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: clinically suspected or known to have acquired immunodeficiency syndrome (aids),; granulocyte count less than 1000/mm3 due to a cause other than severe sepsis (e.g. metastatic or hematological malignancies or chemotherapy),.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-04 with completion listed for 2014-09.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mortality (time frame: 28).

It also tracked 2 secondary outcomes, for example Duration of inotropic and vasopressor support and Severity of organ dysfunction.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 28 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.