Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

It had four arms (groups): 1 (active comparator), 2 (experimental), 3 (experimental) and 4 (experimental).

Hydrocortisone and convention glycemic control.

Hydrocortisone and fludrocortisone and conventional glucose control.

Hydrocortisone and intensive insulin therapy.

The registry classes the interventions as drug.

Who Took Part

The registry lists 508 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: Need for vasopressor to maintain systemic arterial tension above 90 mmHg. Multiple organ dysfunction as defined by a SOFA score ³ 8.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: less than 18 years old; moribund (i.e. expected to die on day of intensive care unit admission).

How the Study Was Run

Design: randomized, factorial and triple-blind.

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

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2006-01 with completion listed for 2009-01.

It ran at 8 sites in France (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): In-hospital mortality (time frame: Day 180).

It also tracked 8 secondary outcomes, for example Secondary outcomes :, 90-day and 180-day mortality, Duration of life-supporting treatments (i.e. vasopressors and mechanical ventilation), Time to resolve multiple organ dysfunction, i.e. to obtain a SOFA score < 8, Hospital length of stay and Muscle weakness at discharge from intensive care unit, 90-day and 180-day.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 508 people.

With 508 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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