Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)

What Was Tested

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

The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.

The registry classes the interventions as drug.

More on the Plan

Severe sepsis and septic shock have a high mortality.

In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis.

Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.

Who Took Part

The registry lists 600 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.

The full record lists 1 inclusion and 12 exclusion criteria; among the exclusions: age \< 18 years; known allergy against hydroxyethyl starch; intracerebral hemorrhage.

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.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2003-04 with completion listed for 2005-09.

It ran at 16 sites in Germany (16).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mortality (28 day). Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS]).

It also tracked 8 secondary outcomes, for example Frequency of acute kidney failure, Time until hemodynamic stabilization, Frequency of therapy with vasopressors (in days), Course of SOFA sub-scores, Frequency of hemorrhages under hydroxyethyl starch (HES) therapy and Frequency of hypoglycemia under intensive insulin therapy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 600 people.

With 600 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.