Hyperinsulinemic Therapy in Sepsis

What Was Tested

The trial (not phased) is built around Insulin (regular human).

Insulin regulates blood sugar and acts to suppress inflammation.

This therapy is called dextrose/insulin clamp.

It had three arms (groups): Tight Glucose Control Hyperinsulinemic Group (experimental), Non-Tight Glucose Control Hyperinsulinemic Group (experimental) and Standard Insulin Protocol Group (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 planned participants were the target.

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: Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: age less than 18 years old; patients who cannot provide informed consent and there is no surrogate decision maker; A delay of more than 24 hours between eligibility and randomization.

How the Study Was Run

Design: randomized, factorial and open-label.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2010-11 with completion listed for 2013-12.

It ran at 3 sites in Canada (2) and Saudi Arabia (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glucose Control (time frame: During ICU stay (average one week)).

It also tracked 1 secondary outcome, for example Inflammatory cytokines and biochemical hormonal response.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 15 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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