Clinical trial NCT06759259: Mannitol Administration for Delerium Prevention
Official title: Mannitol Adjuvant Administration for Delerium Prevention
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Infarction (MI)
Delirium, Intensive Care Unit, Randomised Controlled Trial
Keywords: myocardial infarction
delirium
prevention
inflammation
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: delirium
timeFrame: 1-14 days
Secondary outcomes:
measure: In-hospital mortality
timeFrame: 1-30 days
measure: In-hospital LOS
timeFrame: 1-30 lays
measure: ICU-LOS
timeFrame: 1-30 days
measure: Re-hospitalization due to MACE
timeFrame: 1-90 days
Other outcomes:
measure: Dynamics of brain damage markers
timeFrame: 1, 3, 7 days
measure: Dynamics of markers of systemic inflammation
timeFrame: 1, 3, 7 days
measure: Early adverse LV remodeling
timeFrame: 1, 3, 7 days
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology Reserch Institute Tomsk National Research Centre
state: Tomskaya Oblast
Study officials:
affiliation: Tomsk NRMC
name: Oleg Panteleev, MD
role: PRINCIPAL_INVESTIGATOR
References: