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Completed

NCT Number: NCT06759259

Mannitol Administration for Delerium Prevention

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. delirium

    Time frame: 1-14 days

    Development of delirium during hospitalization

Secondary outcomes

  1. In-hospital mortality

    Time frame: 1-30 days

    Death during hospitalization from all causes

  2. In-hospital LOS

    Time frame: 1-30 lays

    Lenght of stay in hospital

  3. ICU-LOS

    Time frame: 1-30 days

    Lenght of stay in ICU

  4. Re-hospitalization due to MACE

    Time frame: 1-90 days

    Re-hospitalization due to MACE

Other outcomes

  1. Dynamics of brain damage markers

    Time frame: 1, 3, 7 days

    Dynamics of brain damage markers (NSE, S100β)

  2. Dynamics of markers of systemic inflammation

    Time frame: 1, 3, 7 days

    Dynamics of markers of systemic inflammation (IL-1, IL-6, IL-8, procalcitonin, presepsin)

  3. Early adverse LV remodeling

    Time frame: 1, 3, 7 days

    Increase in ESV by 15% from the baseline

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

Mannitol Adjuvant Administration for Delerium Prevention

Acronym: MAD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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