CClinicalTrials.gg
CompletedNCT06759259MADUpdated Jun 24, 2026

Mannitol Administration for Delerium Prevention

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • myocardial infarction
  • delirium
  • prevention
  • inflammation
03

In context

Myocardial Infarction

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • A known pathological process in the brain, psychiatric disorders
  • Impossibility of conducting an assessment CAM-ICU
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. delirium

    Development of delirium during hospitalization

    Time frame: 1-14 days

Secondary outcomes

  1. In-hospital mortality

    Death during hospitalization from all causes

    Time frame: 1-30 days

  2. In-hospital LOS

    Lenght of stay in hospital

    Time frame: 1-30 lays

  3. ICU-LOS

    Lenght of stay in ICU

    Time frame: 1-30 days

  4. Re-hospitalization due to MACE

    Re-hospitalization due to MACE

    Time frame: 1-90 days

Other outcomes

  1. Dynamics of brain damage markers

    Dynamics of brain damage markers (NSE, S100β)

    Time frame: 1, 3, 7 days

  2. 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

  3. Early adverse LV remodeling

    Increase in ESV by 15% from the baseline

    Time frame: 1, 3, 7 days

07

Study locations

1 site
  • Cardiology Reserch Institute Tomsk National Research Centre
    Tomsk, Tomsk Oblast 634012, Russia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06759259
Lead sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Responsible party
Sponsor
First posted
Jan 6, 2025
Start date
Dec 29, 2024
Primary completion
Feb 1, 2025
Completion
Oct 1, 2025
Last update
Jun 24, 2026

Study contacts

Oleg Panteleev, MD
principal investigator · Tomsk NRMC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion