Mannitol Administration for Delerium Prevention (MAD)

Mannitol Adjuvant 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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction (MI); Delirium, Intensive Care Unit, Randomised Controlled Trial

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delirium	Development of delirium during hospitalization	1-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Death during hospitalization from all causes	1-30 days
In-hospital LOS	Lenght of stay in hospital	1-30 lays
ICU-LOS	Lenght of stay in ICU	1-30 days
Re-hospitalization due to MACE	Re-hospitalization due to MACE	1-90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamics of brain damage markers	Dynamics of brain damage markers (NSE, S100β)	1, 3, 7 days
Dynamics of markers of systemic inflammation	Dynamics of markers of systemic inflammation (IL-1, IL-6, IL-8, procalcitonin, presepsin)	1, 3, 7 days
Early adverse LV remodeling	Increase in ESV by 15% from the baseline	1, 3, 7 days

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Oleg Panteleev, MD, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: delirium; myocardial infarction; prevention; inflammation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathologic Processes; Heart Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Inflammation; Myocardial Infarction
• Other Study ID Numbers: 231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No