Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05864677 |
Other study ID # |
KE-0254/235/11/2022 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 15, 2023 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
May 2023 |
Source |
Medical University of Lublin |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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). Delirium is a serious complication that prolongs hospital stay and
contributes to poor outcomes and increased risk of death. The pathomechanisms of delirium are
still not very well recognized and there are several theories that seem to explain it. The
most important pathomechanisms of delirium are associated with cerebral ischaemia, disorders
in acetylcholinergic system, disorders in neuronal plasticity and oxidative stress.
Cerebrolysin, a mixture of various peptides obtained from the structural proteins of the
pig's brain, possesses strong antioxidative and neuronal protective properties. Cerebrolysin
is recommended to treat patients with dementia, after cerebral ischemia and after brain
trauma. It has been documented that Cerebrolysin reduces the severity of secondary brain
damage after ischemia, improving neuronal plasticity and then cognitive function, and
reducing severity of oxidative stress. Based on these properties it can be speculated that
Cerebrolysin may reduce the risk of postoperative delirium in patients undergoing elective
surgery, which are associated with a high risk of postoperative delirium.
Description:
The main hypothesis: Cerebrolysin may be an effective drug to treat dementia and
post-ischemic damage. It may improve neuronal plasticity, increase the activity of
acetychocholinergic system, and reduces the severity of oxidative stress - all of them are
the main factors corresponding to the risk of delirium.
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.
After signing informed consent patients will be randomized using a double-blinded envelope
method into two groups: C - control and CER - patients receiving Cerebrolysin at the dose of
50 mL before surgery followed by 50 mL on the morning of days 1,2,3 and 4. 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. Additionally, 10 mL of
plasma will be collected to assess the following neuro-biomarkers: S100β protein,
neurofilament light protein (HNL), Tau protein, ubiquitin carboxy-terminal hydrolase L1
(UCH-L1), and myelin basic protein (MBP). All these biomarkers will be assessed
pre-operatively (before Cerebrolysin administration) and on postoperative days 1, 3, and 5.
Additionally, routine blood examinations such as arterial blood analysis, blood morphology
with NLR and PLR, serum albumin, and CRP will be measured at the same time points.