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NCT Number: NCT06677502

Cerebrolysin in Critically Ill Patients With Delirium

Delirium is a severe problem in critically ill patients, and it is associated with increased morbidity, mortality, and extended stay in hospital. The pathophysiology of delirium is multifactorial and still poorly recognized. Several authors proposed different pathomechanisms of delirium. The most likely of these are a metabolic response to cerebral hypoxia/hyperoxia, oxidative stress with excessive reactive oxygen species production, neuroinflammation following general inflammatory response, disorders in neurotransmitters, especially impaired cholinergic and dopaminergic transmissions and dysregulation of tryptophan metabolisms including kynurenine and serotonin/melatonin pathways. The multifactorial pathomechanism of delirium significantly reduces targeted therapy. Due to cerebrolysin properties, it seems reasonable to conclude that this substance is effective in the prevention and treatment of delirium in critically ill patients. Cerebrolysin is commonly used in neurologic patients treated for dementia and Alzheimer's disease. It possesses antioxidative properties, which reduce the severity of post-ischaemic neuronal dysfunction and improve neuronal plasticity. It also increases acetylcholinesterase and butyrylcholinesterase in a dose-dependent manner, improving neuronal plasticity.

Additionally, cerebrolysin reduces neuroinflammation and neuronal cell apoptosis by activating toll-like receptor pathways. These properties closely correspond to the pathomechanism of delirium.

Therefore, the aim of this study is to analyze the effectiveness of treatment with Cerebrolysin in critically ill patients with delirium.

This study enrolls adult critically ill patients. Prior to delirium detection, the Richmond Agitation-Sedation Scale (RASS) is used to assess the level of consciousness. Patients with RASS-4 or -5 were excluded from the analysis, as these disorders of consciousness preclude the determination of the degree of delirium, which is a requisite component of the study. Delirium is detected by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC). Additionally, the Montreal Cognitive Assessment Scale is used to detect mild cognitive impairment. The primary endpoint of this study is an analysis of the prevalence and severity of delirium symptoms. The secondary endpoint is an analysis of the duration of delirium.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Confusion Critical Illness Delirium Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Department of Anaesthesiology and Intensive Therapy Medical University of Lublin

Lubin, Lublin Voivodeship, 20-090, Poland

About this study

This is an observational, interventional study. Adult critically ill patients treated with mechanical ventilation due to acute respiratory insufficiency complicating sepsis, septic shock, pneumonia, acute respiratory distress syndrome (ARDS) and polytrauma patients without traumatic brain injury are enrolled to this study. All patients should be treated in accordance with the most up-to date recommendations for the specific disease. None of the patients should be treated with neuroprotective medication before the diagnosis of delirium. Patients are randomized into two groups: CBL - patients treated with cerebrolysin and K - control patients treated without cerebrolysin. Cerebrolysin is administered in a daily dose of 50ml, dissolved in 0.9% NaCl. This mixture is infused for one hour. The treatment is initiated when the delirium is detected and continued for seven consecutive days.

The diagnosis of delirium is based on four principal criteria of the CAM-ICU test: 1/ Sudden onset of disturbance, 2/ Lack of focus of attention, 3/ Altered state of consciousness, and 4/ Disorganised thinking. Of these, criterion feature 2 is regarded as the most crucial in establishing a diagnosis of delirium.

The ICDSC method takes into account eight criteria which include: The ICDSC method considers eight criteria that include: 1/ any disturbance of consciousness (RASS other than 0), 2/ attention deficit disorder, 3/ disorientation, 4/ hallucinations, 5/ psychomotor agitation or retardation, 6/ speech or mood disturbances, 7/ disturbance of sleep-wake cycle, 8/ diurnal variability of symptoms. One point is added for each criterion. A score of 4 points or higher indicates a diagnosis of full-blown delirium, while a score of 1 to 3 points indicates subclinical delirium.

The initial detection of delirium using the CAM-ICU and ICDSC scales is conducted one to three days after the cessation of sedative infusion when the patient's sedation level reaches 3 on the RASS scale. Subsequent follow-up analysis is performed on days 7-8 after the diagnosis of delirium.

The MoCA test is performed in the days 7-8. The MoCA test is assessed using the Geriatric Assessment Tool Kit (https://geriatrictoolkit.missouri.edu) with the following points: 1/ Short term memory, 2/ Visuospatial abilities, 3/ Executive functions, 4/ attention and concentration, 5/ working memory, 6/ language, 7/ Orientation to time and place. A score of 24 points or less is the cut-off for mild cognitive impairment, while 19 points or less for dementia diagnosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18,
  • symptoms of delirium,
  • critical illness treated in Intensive Care Unit

Exclusion criteria

  • pregnancy
  • traumatic brain injury,
  • neuroinflammatory diseases

Treatment and study plan

Cerebrolysin

Drug

Patients were randomized into two groups: CBL - patients treated with cerebrolysin at the daily dose of 50 mL, and K - control patients treated without cerebrolysin. Cerebrolysin was administrated intravenously on the day the delirium was detected and then for seven consecutive days.

Saline Solution - IV

Other

Patients enrolled in group K received the infusion of 0.9% Saline solution at a volume of 250 mL.

Primary outcomes

  1. CAM-ICU test

    Time frame: seven days

    Cerebrolysin, 50 mL daily administered intravenously for seven consecutive days, reduces or alleviates the severity of delirium detected by the CAM-ICU test.

  2. ICDSC test

    Time frame: seven days

    Cerebrolysin, 50 mL daily administered intravenously for seven consecutive days, reduces or alleviates the severity of delirium detected by the ICDSC test.

Secondary outcomes

  1. MoCA test

    Time frame: seven days

    Cerebrolysin infusion at the dose of 50 mL daily administrated intravenously reduces or alleviates the severity of cognitive impairment detected by the MoCA test.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

The Usefulness of Cerebrolysin in Alleviating the Severity of Delirium in Critically Ill Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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