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Mannitol Administration for Delerium Prevention

Mannitol Adjuvant Administration for Delerium Prevention

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06759259
Acronym
MAD
Enrollment
50
Registered
2025-01-06
Start date
2024-12-29
Completion date
2025-10-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Intensive Care Unit, Randomised Controlled Trial, Myocardial Infarction (MI)

Keywords

myocardial infarction, delirium, prevention, inflammation

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 65 and over * Myocardial infarction in the first day of illness ("pain to door" time \< 254 hours) * Serum CRP \> 25 mg/L

Exclusion criteria

* A known pathological process in the brain, psychiatric disorders * Impossibility of conducting an assessment CAM-ICU

Design outcomes

Primary

MeasureTime frameDescription
delirium1-14 daysDevelopment of delirium during hospitalization

Secondary

MeasureTime frameDescription
In-hospital mortality1-30 daysDeath during hospitalization from all causes
In-hospital LOS1-30 laysLenght of stay in hospital
ICU-LOS1-30 daysLenght of stay in ICU
Re-hospitalization due to MACE1-90 daysRe-hospitalization due to MACE

Countries

Russia

Contacts

PRINCIPAL_INVESTIGATOROleg Panteleev, MD

Tomsk NRMC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026