Cerebrolysin in Critically Ill Patients With Delirium

What Was Tested

The trial (not phased) is built around Cerebrolysin.

The pathophysiology of delirium is multifactorial and still poorly recognized.

Several authors proposed different pathomechanisms of delirium.

It had two arms (groups): Cerebrolysin arm. (experimental) and Control arm. (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

This is an observational, interventional study.

Adult critically ill patients treated with mechanical ventilation due to acute respiratory insufficiency complicating sepsis, septic shock, pneumonia, acute respiratory distress syndrome (ARDS) and polytrauma patients without traumatic brain injury are enrolled to this study.

All patients should be treated in accordance with the most up-to date recommendations for the specific disease.

None of the patients should be treated with neuroprotective medication before the diagnosis of delirium.

Who Took Part

The registry lists 500 planned participants were the target.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: Age \> 18,. Symptoms of delirium,. Critical illness treated in Intensive Care Unit.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: traumatic brain injury,; neuroinflammatory diseases.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Cerebrolysin and who got the comparison, which limits bias.

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

Only one side, usually the participants, was kept unaware of whether Cerebrolysin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2024-01-01 with completion listed for 2025-06-30.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): CAM-ICU test (time frame: seven days). ICDSC test (time frame: seven days).

It also tracked 1 secondary outcome, for example MoCA test.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cerebrolysin in 500 people.

With 500 participants it is a large trial for this field.

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

More context: the Cerebrolysin compound page, all human trials.