An interventional study of Cerebrolysin and Saline Solution - IV in Cognitive Impairment, sponsored by Medical University of Lublin. Enrolling by invitation at 1 site in Poland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Medical University of Lublin · Not applicable, Interventional, and Treatment
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.
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 500 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Medical University of Lublin is the lead sponsor of 62 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients in group CER received Cerebrolysin infusion at the dose of 50 mL solved in 0.9% NaCl for seven consecutive days, after delirium diagnose.
Drug: Cerebrolysin
Patients in group K (control) received 0.9% NaCl for seven consecutive days.
Other: Saline Solution - IV
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.
Patients enrolled in group K received the infusion of 0.9% Saline solution at a volume of 250 mL.
CAM-ICU test
Cerebrolysin, 50 mL daily administered intravenously for seven consecutive days, reduces or alleviates the severity of delirium detected by the CAM-ICU test.
Time frame: seven days
ICDSC test
Cerebrolysin, 50 mL daily administered intravenously for seven consecutive days, reduces or alleviates the severity of delirium detected by the ICDSC test.
Time frame: seven days
MoCA test
Cerebrolysin infusion at the dose of 50 mL daily administrated intravenously reduces or alleviates the severity of cognitive impairment detected by the MoCA test.
Time frame: seven days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cerebrolysin
Medical University of Lublin