Neurocognitive DisordersCereb-PODNCT05864677
Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery
A study testing Cerebrolysin in people with Neurocognitive Disorders and Surgery-Complications, run by Medical University of Lublin at 1 site in Poland.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurocognitive Disorders, Surgery-Complications, Critical Illness
- What is being tested?
- Cerebrolysin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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,
Who cannot join
- any neurological disease,
- intra-operative cardiac arrest,
- perioperative blood transfusion,
- cardiopulmonary bypass (extracorporeal circulation) longer than 120 min,
- any reoperation,
- lack of signed consent for this study,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Cerebrolisin in the Prevention of Postoperative Delirium in Cardiac Surgery Patients
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.
Read the detailed 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.
- Conditions
- Neurocognitive Disorders, Surgery-Complications, Critical Illness, Brain Damage, Cardiac Disease
- Being tested
- Cerebrolysin
- Medical subject headings
- Neurocognitive Disorders, Critical Illness, Brain Injuries, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Patients, who will be randomized to group CER, will receive Cerebrolysin at the dose of 50 mL before surgery, followed by 50 mL on the morning of days 1,2,3, and 4.
| Study group | Role | What they receive |
|---|---|---|
| Group S - standard treatment | No intervention | 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. |
| Group CER - treatment with Cerebrolysin | Active comparator | Patients will be treated in accordance with the current recommendations and receiving additional treatment with Cerebrolysin. Receives: Drug: Cerebrolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point is to analyze changes in CAM-ICU test the incidence of delirium on the postoperative day 5.
The incidence of delirium will be primarily diagnosed with the CAM-ICU test. The CAM-ICU test will be performed one day before surgery (baseline) and on postoperative day 5. Delirium will be diagnosed if the patient's mental state changes from their baseline and/or fluctuation in mental status.
Measured: baseline and 5 days
The primary end-point is to analyze changes in MoCA scale the incidence of delirium on the postoperative day 5.
The incidence of postoperative cognitive impairment will be diagnosed with the Montreal Cognitive Assessment Scale (MoCA) performed one day before surgery (baseline) and on postoperative day 5. Cognitive dysfunction will be diagnosed when patients score 22 or less on the MoCA scale. Patients who scored 22 or less before surgery will be excluded.
Measured: 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.
The incidence of postoperative cognitive impairment will be diagnosed with the Mini-Mental State Examination (MMSE) test performed one day before surgery (baseline) and on postoperative day 5. Cognitive dysfunction will be diagnosed when patients score 22 or less on the MMSE test. Patients who scored 22 or less before surgery will be excluded.
Measured: baseline and 5 days
Secondary outcomes (1)
The secondary end-points are the analysis of length of hospital stay.
The length of hospital stay will be calculated in patients receiving Cerebrolysin and treated without Cerebrolysin. The length of hospital stay and outcome will be analyzed one month after surgery. All patients without postoperative delirium who required prolonged hospitalization (more than seven days) due to wound infection or cardiac arrhythmias will be excluded from this analysis.
Measured: one month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult patients undergoing CABG under general anesthesia will be included in this 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864677
- Sponsor's protocol ID
- KE-0254/235/11/2022
- Acronym
- Cereb-POD
- Status last verified
- May 2023
- First submitted
- 14 Feb 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cerebrolisin in the Prevention of Postoperative Delirium in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05864677
- Acronym / sponsor ID
- Cereb-POD / KE-0254/235/11/2022
- Conditions
- Neurocognitive Disorders, Surgery-Complications, Critical Illness, Brain Damage, Cardiac Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Adult patients undergoing CABG under general anesthesia will be included in this 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.
| Arm | Type | Receives |
|---|---|---|
| Group S - standard treatment | No intervention | –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. |
| Group CER - treatment with Cerebrolysin | Active comparator | Drug: CerebrolysinPatients will be treated in accordance with the current recommendations and receiving additional treatment with Cerebrolysin. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (6 listed)
- any neurological disease,
- intra-operative cardiac arrest,
- perioperative blood transfusion,
- cardiopulmonary bypass (extracorporeal circulation) longer than 120 min,
- any reoperation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebrolysinPatients, who will be randomized to group CER, will receive Cerebrolysin at the dose of 50 mL before surgery, followed by 50 mL on the morning of days 1,2,3, and 4. | Drug | Group CER - treatment with Cerebrolysin |
Primary outcome
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 incidence of delirium will be primarily diagnosed with the CAM-ICU test. The CAM-ICU test will be performed one day before surgery (baseline) and on postoperative day 5. Delirium will be diagnosed if the patient's mental state changes from their baseline and/or fluctuation in mental status.
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 incidence of postoperative cognitive impairment will be diagnosed with the Montreal Cognitive Assessment Scale (MoCA) performed one day before surgery (baseline) and on postoperative day 5. Cognitive dysfunction will be diagnosed when patients score 22 or less on the MoCA scale. Patients who scored 22 or less before surgery will be excluded.
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
The incidence of postoperative cognitive impairment will be diagnosed with the Mini-Mental State Examination (MMSE) test performed one day before surgery (baseline) and on postoperative day 5. Cognitive dysfunction will be diagnosed when patients score 22 or less on the MMSE test. Patients who scored 22 or less before surgery will be excluded.
1 secondary outcome
The secondary end-points are the analysis of length of hospital stay.
Time frame: one month after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebrolysin in people with Neurocognitive Disorders and Surgery-Complications, run by Medical University of Lublin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.