Early Insulin and Development of ARDS

What Was Tested

This registered phase 2 trial tested Insulin (regular human).

Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure.

Symptoms usually develop within 24 to 48 hours of an original injury or illness, and people with ALI/ARDS typically require care in the intensive care unit (ICU).

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

While participants are in the hospital, their medical records will be reviewed to gather information on medical and family history, demographics, vital signs, laboratory test results, x-ray findings, and lung function.

Study researchers will also monitor participants for the development of severe lung failure or other organ failures.

Who Took Part

Enrollment: 18 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: Diagnosed with severe sepsis, which is defined as sepsis AND one or more signs of organ dysfunction or hypotension.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: diabetic ketoacidosis; severe chronic liver disease with child-pugh score greater than 10 (class c); lack of any available iv access for insulin infusion.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-04 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen (time frame: Measured at Day 1, 3 and 7).

It also tracked 1 secondary outcome, for example Murray Lung Injury Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 18 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.