Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery

NCT05864677 | Unknown

• 1 other identifier: KE-0254/235/11/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurocognitive Disorders; Surgery-Complications; Critical Illness; Brain Damage; Cardiac Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  baseline and 5 days

Secondary Outcomes (1)

• The secondary end-points are the analysis of length of hospital stay.

  one month after surgery.

Study Arms (2)

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.

Drug: Cerebrolysin

Interventions

Cerebrolysin DRUG

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.

Group CER - treatment with Cerebrolysin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Medical University

Lublin, 20-059, Poland

Location

MeSH Terms

Conditions

Neurocognitive Disorders; Critical Illness; Brain Injuries; Heart Diseases

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: May 18, 2023
• Study Start: January 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-05

Locations

PL (1)