- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05864677
Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery (Cereb-POD)
Efficacy of Cerebrolisin in the Prevention of Postoperative Delirium in Cardiac Surgery Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wojciech Dabrowski
- Phone Number: +487244332
- Email: w.dabrowski5@yahoo.com
Study Contact Backup
- Name: Dorota Siwicka-Gieroba
- Phone Number: +487244332
- Email: dsiw.@wp.pl
Study Locations
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Lublin, Poland, 20-059
- Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group S - standard treatment
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.
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Active Comparator: Group CER - treatment with Cerebrolysin
Patients will be treated in accordance with the current recommendations and receiving additional treatment with Cerebrolysin.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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baseline and 5 days
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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
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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.
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baseline and 5 days
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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
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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.
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baseline and 5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary end-points are the analysis of length of hospital stay.
Time Frame: one month after surgery.
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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.
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one month after surgery.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Wounds and Injuries
- Confusion
- Neurobehavioral Manifestations
- Disease Attributes
- Craniocerebral Trauma
- Trauma, Nervous System
- Heart Diseases
- Delirium
- Brain Injuries
- Emergence Delirium
- Critical Illness
- Neurocognitive Disorders
- Physiological Effects of Drugs
- Neuroprotective Agents
- Protective Agents
- Nootropic Agents
- Cerebrolysin
Other Study ID Numbers
- KE-0254/235/11/2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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