Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery

What Was Tested

This registered not phased trial tested Cerebrolysin.

Postoperative delirium (POD) and postoperative neuropsychological dysfunction are frequently noted in critically ill patients undergoing elective or emergency surgery and treated in the intensive care unit (ICU).

The pathomechanisms of delirium are still not very well recognized and there are several theories that seem to explain it.

It had two arms (groups): Group S - standard treatment (no intervention) and Group CER - treatment with Cerebrolysin (active comparator).

Patients will be treated in accordance with the current recommendations. Patients with every postoperative complication (severe postoperative bleeding, wound infection, hemodynamically unstable) and those undergoing reoperation will be excluded from this study.

Patients will be treated in accordance with the current recommendations and receiving additional treatment with Cerebrolysin.

The registry classes the interventions as drug.

More on the Plan

The study will be conducted in accordance with the Declaration of Helsinki, after obtaining approval from the Bioethical Committee and signed informed consent from each patient eligible to participate in the study.

The Montreal Cognitive Assessment (MoCA) scale and Mini-Mental State Examination Score (MMSE) will be performed a day before surgery to detect eventual neuropsychological disorders before surgery.

The postoperative delirium will be detected with MoCA, MMSE and the Confusion Assessment Method for ICU (CAM-ICU) performed on day 5 after surgery.

All these biomarkers will be assessed pre-operatively (before Cerebrolysin administration) and on postoperative days 1, 3, and 5.

Who Took Part

The registry lists 100 planned participants were the target.

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: Adult patients aged 18 - 90 years (male and female) undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass (extracorporeal circulation) not longer than 120 min. Written informed consent,. Patients without a history of neurology diseases (stroke, cerebral trauma, treated for seizure),. Patients without stenosis of the carotid artery,.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: any neurological disease,; intra-operative cardiac arrest,; perioperative blood transfusion,.

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.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

In this single-blind Cerebrolysin study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2023-01-15 with completion listed for 2024-06-30.

It ran at 1 site in Poland.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The primary end-point is to analyze changes in CAM-ICU test the incidence of delirium on the postoperative day 5 (time frame: baseline and 5 days). The primary end-point is to analyze changes in MoCA scale the incidence of delirium on the postoperative day 5 (time frame: baseline and 5 days). The primary end-point is to analyze changes in MMSE test the incidence of cognitive impairment on the postoperative day 5 (time frame: baseline and 5 days).

It also tracked 1 secondary outcome, for example The secondary end-points are the analysis of length of hospital stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cerebrolysin in 100 people.

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

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