Cognitive ImpairmentNCT06677502
Cerebrolysin in Critically Ill Patients With Delirium
A study testing Cerebrolysin and Saline Solution - IV in people with Cognitive Impairment, run by Medical University of Lublin at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Cerebrolysin and Saline Solution - IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age \> 18,
- symptoms of delirium,
- critical illness treated in Intensive Care Unit
Who cannot join
- pregnancy
- traumatic brain injury,
- neuroinflammatory diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
First Department of Anaesthesiology and Intensive Therapy Medical University of Lublin
Lubin, Lublin Voivodeship, 20-090
About this study
Official title: The Usefulness of Cerebrolysin in Alleviating the Severity of Delirium in Critically Ill Patients
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cognitive Impairment
- Being tested
- Cerebrolysin, Saline Solution - IV
- Keywords
- delirium, critically ill, treatment, Cerebrolysin
- Medical subject headings
- Cognitive Dysfunction, Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
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 - IVOther
Patients enrolled in group K received the infusion of 0.9% Saline solution at a volume of 250 mL.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin arm. | Experimental | 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. Receives: Drug: Cerebrolysin |
| Control arm. | Placebo comparator | Patients in group K (control) received 0.9% NaCl for seven consecutive days. Receives: Other: Saline Solution - IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: seven days
Secondary outcomes (1)
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.
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled to the intervention group (CER group) receive Cerebrolysin for 7 consecutive days at a dose of 50mL daily administrated in 250 mL 0.9% NaCl. Patients enrolled the control group (K group) receive 250 mL 0.9% NaCl.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Dąbrowski, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677502
- Sponsor's protocol ID
- CEREBDEL
- Other IDs
- DS352/2024
- Status last verified
- Dec 2024
- First submitted
- 29 Sep 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nakanishi N, Liu K, Kawauchi A, Okamura M, Tanaka K, Katayama S, Mitani Y, Ota K, Taito S, Fudeyasu K, Masuka Y, Yoshihiro S, Utsumi S, Nishikimi M, Masuda M, Iida Y, Kawai Y, Hatakeyama J, Hifumi T, Unoki T, Kawakami D, Obata K, Katsukawa H, Sumita H, Morisawa T, Takahashi M, Tsuboi N, Kozu R, Takaki S, Haruna J, Fujinami Y, Nosaka N, Miyamoto K, Nakamura K, Kondo Y, Inoue S, Nishida O. Instruments to assess post-intensive care syndrome assessment: a scoping review and modified Delphi method study. Crit Care. 2023 Nov 7;27(1):430. doi: 10.1186/s13054-023-04681-6.
PubMed 37936249Smith HA, Gangopadhyay M, Goben CM, Jacobowski NL, Chestnut MH, Savage S, Rutherford MT, Denton D, Thompson JL, Chandrasekhar R, Acton M, Newman J, Noori HP, Terrell MK, Williams SR, Griffith K, Cooper TJ, Ely EW, Fuchs DC, Pandharipande PP. The Preschool Confusion Assessment Method for the ICU: Valid and Reliable Delirium Monitoring for Critically Ill Infants and Children. Crit Care Med. 2016 Mar;44(3):592-600. doi: 10.1097/CCM.0000000000001428.
PubMed 26565631Landoure G, Sullivan JM, Johnson JO, Munns CH, Shi Y, Diallo O, Gibbs JR, Gaudet R, Ludlow CL, Fischbeck KH, Traynor BJ, Burnett BG, Sumner CJ. Exome sequencing identifies a novel TRPV4 mutation in a CMT2C family. Neurology. 2012 Jul 10;79(2):192-4. doi: 10.1212/WNL.0b013e31825f04b2. Epub 2012 Jun 6. No abstract available.
PubMed 22675077Flores IO, Trevino S, Diaz A. Neurotrophic fragments as therapeutic alternatives to ameliorate brain aging. Neural Regen Res. 2023 Jan;18(1):51-56. doi: 10.4103/1673-5374.331867.
PubMed 35799508Hoel H, Heggelund L, Reikvam DH, Stiksrud B, Ueland T, Michelsen AE, Otterdal K, Muller KE, Lind A, Muller F, Dudman S, Aukrust P, Dyrhol-Riise AM, Holter JC, Troseid M. Elevated markers of gut leakage and inflammasome activation in COVID-19 patients with cardiac involvement. J Intern Med. 2021 Apr;289(4):523-531. doi: 10.1111/joim.13178. Epub 2020 Oct 8.
PubMed 32976665Sharma S, Raj K, Singh S. Protective effects of cerebrolysin against chemotherapy (carmustine) induced cognitive impairment in Albino mice. Drug Chem Toxicol. 2022 Nov;45(6):2769-2779. doi: 10.1080/01480545.2021.1991195. Epub 2021 Oct 21.
PubMed 34674598Liu Z, Hu M, Lu P, Wang H, Qi Q, Xu J, Xiao Y, Fan M, Jia Y, Zhang D. Cerebrolysin alleviates cognitive deficits induced by chronic cerebral hypoperfusion by increasing the levels of plasticity-related proteins and decreasing the levels of apoptosis-related proteins in the rat hippocampus. Neurosci Lett. 2017 Jun 9;651:72-78. doi: 10.1016/j.neulet.2017.04.022. Epub 2017 Apr 27.
PubMed 28458021Kotfis K, Ely EW, Shehabi Y. Intensive care unit delirium-a decade of learning. Lancet Respir Med. 2023 Jul;11(7):584-586. doi: 10.1016/S2213-2600(23)00222-9. No abstract available.
PubMed 37414511Ottens TH, Hermes C, Page V, Oldham M, Arora R, Bienvenu OJ 3rd, van den Boogaard M, Caplan G, Devlin JW, Friedrich ME, van Gool WA, Hanison J, Hansen HC, Inouye SK, Kamholz B, Kotfis K, Maas MB, MacLullich AMJ, Marcantonio ER, Morandi A, van Munster BC, Muller-Werdan U, Negro A, Neufeld KJ, Nydahl P, Oh ES, Pandharipande P, Radtke FM, Raedt S, Rosenthal LJ, Sanders R, Spies CD, Vardy ERLC, Wijdicks EF, Slooter AJC. The Delphi Delirium Management Algorithms. A practical tool for clinicians, the result of a modified Delphi expert consensus approach. Delirium (Bielef). 2024;2024:10.56392/001c.90652. doi: 10.56392/001c.90652. Epub 2024 Jan 12.
PubMed 38348284Kotfis K, Maj P, Szylinska A, Pankowiak M, Reszka E, Ely EW, Marra A. The spectrum of psychological disorders in family members of patients suffering from delirium associated with critical illness: a prospective, observational study. Sci Rep. 2024 Feb 24;14(1):4562. doi: 10.1038/s41598-024-53968-3.
PubMed 38402273Dabrowski W, Siwicka-Gieroba D, Gasinska-Blotniak M, Zaid S, Jezierska M, Pakulski C, Williams Roberson S, Wesley Ely E, Kotfis K. Pathomechanisms of Non-Traumatic Acute Brain Injury in Critically Ill Patients. Medicina (Kaunas). 2020 Sep 13;56(9):469. doi: 10.3390/medicina56090469.
PubMed 32933176Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019 Nov 11;2019(11):CD008900. doi: 10.1002/14651858.CD008900.pub3.
PubMed 31710397Seidl LF, Aigner L. Comparing the biological activity and composition of Cerebrolysin with other peptide preparations. J Med Life. 2024 Jan;17(1):24-27. doi: 10.25122/jml-2024-0129.
PubMed 38737662Ulderich Williams SC, Qaddoumi AI, Meghreblian JT, McBride ME, King SA, Elahi MA, Tuggle D, Heidel RE, Smith LM. Incidence and Risk Factors for ICU-Associated Delirium in the Alert Geriatric Trauma Population. Am Surg. 2024 Jul;90(7):1866-1871. doi: 10.1177/00031348241241707. Epub 2024 Mar 23.
PubMed 38520278Duprey MS, Devlin JW, van der Hoeven JG, Pickkers P, Briesacher BA, Saczynski JS, Griffith JL, van den Boogaard M. Association Between Incident Delirium Treatment With Haloperidol and Mortality in Critically Ill Adults. Crit Care Med. 2021 Aug 1;49(8):1303-1311. doi: 10.1097/CCM.0000000000004976.
PubMed 33861548
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Cerebrolysin in Alleviating the Severity of Delirium in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06677502
- Acronym / sponsor ID
- CEREBDEL
- Conditions
- Cognitive Impairment
- Keywords
- delirium, critically ill, treatment, Cerebrolysin
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Nov 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients enrolled to the intervention group (CER group) receive Cerebrolysin for 7 consecutive days at a dose of 50mL daily administrated in 250 mL 0.9% NaCl. Patients enrolled the control group (K group) receive 250 mL 0.9% NaCl.
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin arm. | Experimental | Drug: CerebrolysinPatients in group CER received Cerebrolysin infusion at the dose of 50 mL solved in 0.9% NaCl for seven consecutive days, after delirium diagnose. |
| Control arm. | Placebo comparator | Other: Saline Solution - IVPatients in group K (control) received 0.9% NaCl for seven consecutive days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age \> 18,
- symptoms of delirium,
- critical illness treated in Intensive Care Unit
Key exclusion criteria (3 listed)
- pregnancy
- traumatic brain injury,
- neuroinflammatory diseases
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 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. | Drug | Cerebrolysin arm. |
| Saline Solution - IVPatients enrolled in group K received the infusion of 0.9% Saline solution at a volume of 250 mL. | Other | Control arm. |
Primary outcome
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.
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.
1 secondary outcome
MoCA test
Time frame: seven days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Results publication: PubMed 37936249Nakanishi N, Liu K, Kawauchi A, Okamura M, Tanaka K, Katayama S, Mitani Y, Ota K, Taito S, Fudeyasu K, Masuka Y, Yoshihiro S, Utsumi S, Nishikimi M, Masuda M, Iida Y, Kawai Y, Hatakeyama J, Hifumi T, Unoki T, Kawakami D, Obata K, Katsukawa H, Sumita H, Morisawa T, Takahashi M, Tsuboi N, Kozu R, Takaki S, Haruna J, Fujinami Y, Nosaka N, Miyamoto K, Nakamura K, Kondo Y, Inoue S, Nishida O. Instruments to assess post-intensive care syndrome assessment: a scoping review and modified Delphi method study. Crit Care. 2023 Nov 7;27(1):430. doi: 10.1186/s13054-023-04681-6.
- Results publication: PubMed 26565631Smith HA, Gangopadhyay M, Goben CM, Jacobowski NL, Chestnut MH, Savage S, Rutherford MT, Denton D, Thompson JL, Chandrasekhar R, Acton M, Newman J, Noori HP, Terrell MK, Williams SR, Griffith K, Cooper TJ, Ely EW, Fuchs DC, Pandharipande PP. The Preschool Confusion Assessment Method for the ICU: Valid and Reliable Delirium Monitoring for Critically Ill Infants and Children. Crit Care Med. 2016 Mar;44(3):592-600. doi: 10.1097/CCM.0000000000001428.
- Results publication: PubMed 22675077Landoure G, Sullivan JM, Johnson JO, Munns CH, Shi Y, Diallo O, Gibbs JR, Gaudet R, Ludlow CL, Fischbeck KH, Traynor BJ, Burnett BG, Sumner CJ. Exome sequencing identifies a novel TRPV4 mutation in a CMT2C family. Neurology. 2012 Jul 10;79(2):192-4. doi: 10.1212/WNL.0b013e31825f04b2. Epub 2012 Jun 6. No abstract available.
- Results publication: PubMed 35799508Flores IO, Trevino S, Diaz A. Neurotrophic fragments as therapeutic alternatives to ameliorate brain aging. Neural Regen Res. 2023 Jan;18(1):51-56. doi: 10.4103/1673-5374.331867.
- Results publication: PubMed 32976665Hoel H, Heggelund L, Reikvam DH, Stiksrud B, Ueland T, Michelsen AE, Otterdal K, Muller KE, Lind A, Muller F, Dudman S, Aukrust P, Dyrhol-Riise AM, Holter JC, Troseid M. Elevated markers of gut leakage and inflammasome activation in COVID-19 patients with cardiac involvement. J Intern Med. 2021 Apr;289(4):523-531. doi: 10.1111/joim.13178. Epub 2020 Oct 8.
- Results publication: PubMed 34674598Sharma S, Raj K, Singh S. Protective effects of cerebrolysin against chemotherapy (carmustine) induced cognitive impairment in Albino mice. Drug Chem Toxicol. 2022 Nov;45(6):2769-2779. doi: 10.1080/01480545.2021.1991195. Epub 2021 Oct 21.
- Results publication: PubMed 28458021Liu Z, Hu M, Lu P, Wang H, Qi Q, Xu J, Xiao Y, Fan M, Jia Y, Zhang D. Cerebrolysin alleviates cognitive deficits induced by chronic cerebral hypoperfusion by increasing the levels of plasticity-related proteins and decreasing the levels of apoptosis-related proteins in the rat hippocampus. Neurosci Lett. 2017 Jun 9;651:72-78. doi: 10.1016/j.neulet.2017.04.022. Epub 2017 Apr 27.
- Results publication: PubMed 37414511Kotfis K, Ely EW, Shehabi Y. Intensive care unit delirium-a decade of learning. Lancet Respir Med. 2023 Jul;11(7):584-586. doi: 10.1016/S2213-2600(23)00222-9. No abstract available.
- Results publication: PubMed 38348284Ottens TH, Hermes C, Page V, Oldham M, Arora R, Bienvenu OJ 3rd, van den Boogaard M, Caplan G, Devlin JW, Friedrich ME, van Gool WA, Hanison J, Hansen HC, Inouye SK, Kamholz B, Kotfis K, Maas MB, MacLullich AMJ, Marcantonio ER, Morandi A, van Munster BC, Muller-Werdan U, Negro A, Neufeld KJ, Nydahl P, Oh ES, Pandharipande P, Radtke FM, Raedt S, Rosenthal LJ, Sanders R, Spies CD, Vardy ERLC, Wijdicks EF, Slooter AJC. The Delphi Delirium Management Algorithms. A practical tool for clinicians, the result of a modified Delphi expert consensus approach. Delirium (Bielef). 2024;2024:10.56392/001c.90652. doi: 10.56392/001c.90652. Epub 2024 Jan 12.
- Results publication: PubMed 38402273Kotfis K, Maj P, Szylinska A, Pankowiak M, Reszka E, Ely EW, Marra A. The spectrum of psychological disorders in family members of patients suffering from delirium associated with critical illness: a prospective, observational study. Sci Rep. 2024 Feb 24;14(1):4562. doi: 10.1038/s41598-024-53968-3.
- Results publication: PubMed 32933176Dabrowski W, Siwicka-Gieroba D, Gasinska-Blotniak M, Zaid S, Jezierska M, Pakulski C, Williams Roberson S, Wesley Ely E, Kotfis K. Pathomechanisms of Non-Traumatic Acute Brain Injury in Critically Ill Patients. Medicina (Kaunas). 2020 Sep 13;56(9):469. doi: 10.3390/medicina56090469.
- Results publication: PubMed 31710397Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019 Nov 11;2019(11):CD008900. doi: 10.1002/14651858.CD008900.pub3.
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
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 and Saline Solution - IV in people with Cognitive Impairment, 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 31 Dec 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
CAM-ICU test (time frame: seven days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06677502, which also lists 18 linked publications.
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 31 Dec 2024.