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Trial · Interventional

Enrolling by invitationNot applicableRegistry data

Cerebrolysin in Critically Ill Patients With Delirium

NCTNCT06677502 (opens ClinicalTrials.gov in a new tab)Other idCEREBDELOther idDS352/2024
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Enrolling by invitation
Phase
Not applicable
Enrollment
500 participants (estimated)
Sponsor
Medical University of Lublin · Other
Design
Randomized · Single masking
Countries
1 country

Poland

Start
1 Jan 2024
Primary completion
30 Jun 2025 (estimated)
Completion
31 Dec 2025 (estimated)
First posted
6 Nov 2024
Last update posted
31 Dec 2024
Conditions
Cognitive Impairment

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. N/A

    Cerebrolysin in Critically Ill Patients With Delirium

    NCT06677502

    1 Jan 2024 to est. 31 Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CerebrolysinDrug
  • Saline Solution - IVOther

Arms2

  • Experimental

    Cerebrolysin arm.

    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.

  • Placebo comparator

    Control arm.

    Patients in group K (control) received 0.9% NaCl for seven consecutive days.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. CAM-ICU test

    Time frame · seven days

    Registry description

    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

    Registry description

    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)

  1. MoCA test

    Time frame · seven days

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Observational study · 2024

2 results

Comparing the biological activity and composition of Cerebrolysin with other peptide preparations.

Seidl et al. 2024Journal of medicine and lifecited by 1

PMID 38737662PMC11080511DOI 10.25122/jml-2024-0129PUB-38737662

CC BY2 results
Download PDFSee results (2)

Indexing hint: Animal study · 2022

4 results

Protective effects of cerebrolysin against chemotherapy (carmustine) induced cognitive impairment in Albino mice.

Sharma et al. 2022Drug and chemical toxicologycited by 5

PMID 34674598DOI 10.1080/01480545.2021.1991195PUB-34674598

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Animal study · 2022

18 results

Cerebrolysin alleviates early brain injury after traumatic brain injury by inhibiting neuroinflammation and apoptosis via TLR signaling pathway.

Lu et al. 2022Acta cirurgica brasileiracited by 23

PMID 36074398PMC9448247DOI 10.1590/acb370605PUB-36074398

CC BY18 results
Download PDFSee results (18)

Indexing hint: Meta-analysis (pooled) · 2019

4 results

Cerebrolysin for vascular dementia.

Cui et al. 2019The Cochrane database of systematic reviewscited by 39

PMID 31710397PMC6844361DOI 10.1002/14651858.cd008900.pub3PUB-31710397

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Animal study · 2017

6 results

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.

Liu et al. 2017Neuroscience letterscited by 33

PMID 28458021DOI 10.1016/j.neulet.2017.04.022PUB-28458021

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

Indexing hint: Review · 2023

Neurotrophic fragments as therapeutic alternatives to ameliorate brain aging.

Flores et al. 2023Neural regeneration researchcited by 14

PMID 35799508PMC9241392DOI 10.4103/1673-5374.331867PUB-35799508

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultNakanishi 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. PMID 37936249
  • ResultSmith 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. PMID 26565631
  • ResultLandoure 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. PMID 22675077
  • ResultHoel 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. PMID 32976665
  • ResultKotfis 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. PMID 37414511
  • ResultOttens 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. PMID 38348284
  • ResultKotfis 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. PMID 38402273
  • ResultDabrowski 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. PMID 32933176
  • ResultUlderich 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. PMID 38520278
  • ResultDuprey 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. PMID 33861548
  • ResultKotfis K, Marra A, Ely EW. ICU delirium - a diagnostic and therapeutic challenge in the intensive care unit. Anaesthesiol Intensive Ther. 2018;50(2):160-167. doi: 10.5603/AIT.a2018.0011. Epub 2018 Jun 8. PMID 29882581
  • ResultEman G, Marsh A, Gong MN, Hope AA. Utility of Screening for Cognitive Impairment at Hospital Discharge in Adult Survivors of Critical Illness. Am J Crit Care. 2022 Jul 1;31(4):306-314. doi: 10.4037/ajcc2022447. PMID 35773197

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 100 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * age \> 18, * symptoms of delirium, * critical illness treated in Intensive Care Unit Exclusion Criteria: * pregnancy * traumatic brain injury, * neuroinflammatory diseases

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