Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC).

It had three arms (groups): Matias protocol (active comparator), Bath protocol (active comparator) and eMPC (active comparator).

A protocol based on the absolute glucose value - Matias protocol (Matias).

A protocol based on the relative glucose change - Bath protocol (Bath).

A computer-based model predictive control algorithm with variable sampling rate (eMPC).

The registry classes the interventions as drug.

More on the Plan

Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol).

Blood glucose was measured in 1-4 hour intervals as requested by protocols.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Patients admitted to the postoperative ICU after elective cardiac surgery.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: insulin allergy.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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 2008-02 with completion listed for 2008-04.

It ran at 1 site in Czechia.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example The safety with respect to hypoglycemia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 120 people.

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.