An observational study in Myocardial Infarction (MI) and Delirium, Intensive Care Unit, Randomised Controlled Trial, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Completed at 1 site in Russia. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Observational
The aim of the study is to evaluate the efficacy of adjuvant administration of mannitol for the prevention of delirium in patients with myocardial infarction.
The pathogenesis of delirium in patients with myocardial infarction has not been fully studied, as a result of which delirium is currently considered a polyetiological syndrome. The ideas about the pathogenesis of delirium are formulated in a number of concepts, among which the neuroinflammatory theory is the most promising for study. The development of a systemic inflammatory reaction of both infectious and aseptic nature can lead to a violation of the permeability of the blood-brain barrier, followed by subclinical cerebral edema and impaired neurotransmitter metabolism. A single study of the adjuvant use of mannitol for the prevention of delirium, conducted in 2020 (Hamiko M.) proved the effectiveness of mannitol in the prevention of delirium in patients who underwent surgical aortic valve replacement, and served as a theoretical and experimental prerequisite for this study.
The study is prospective, randomized, open-label, controlled. It is planned to include 40 patients with myocardial infarction aged 65 years or older on the first day of the disease ("pain-door" \< 24 hours) and signs of a systemic inflammatory response (CRP> 25 mg / L) in the main and control groups in a 1: 1 ratio. All patients will receive standard treatment for myocardial infarction upon admission in accordance with current recommendations. Patients will be randomized using a random number generator, after which patients in the main group will receive adjuvant therapy with mannitol at a dose of 1000 mg / kg according to the following scheme: bolus 250 mg / kg + infusion 66.6 mg / kg / hour until a total dose of 1000 mg / kg is reached. Patients in the control group will receive standard treatment for myocardial infarction. It is planned to evaluate clinical, laboratory, functional data and take blood samples for the study of markers of systemic inflammation and brain damage and other biomarkers on days 1, 3 and 7. Evaluation of remote outcomes is planned on days 30 and 90.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 50 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients in the first day of development of myocardial infarction with signs of systemic inflammation and initial normal mental status and the absence of previously known pathological processes of the brain and psychiatric disorders.
Exclusion Criteria:
delirium
Development of delirium during hospitalization
Time frame: 1-14 days
In-hospital mortality
Death during hospitalization from all causes
Time frame: 1-30 days
In-hospital LOS
Lenght of stay in hospital
Time frame: 1-30 lays
ICU-LOS
Lenght of stay in ICU
Time frame: 1-30 days
Re-hospitalization due to MACE
Re-hospitalization due to MACE
Time frame: 1-90 days
Dynamics of brain damage markers
Dynamics of brain damage markers (NSE, S100β)
Time frame: 1, 3, 7 days
Dynamics of markers of systemic inflammation
Dynamics of markers of systemic inflammation (IL-1, IL-6, IL-8, procalcitonin, presepsin)
Time frame: 1, 3, 7 days
Early adverse LV remodeling
Increase in ESV by 15% from the baseline
Time frame: 1, 3, 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Tomsk National Research Medical Center of the Russian Academy of Sciences