Effect of Minocycline on Delirium Incidence in Critically Ill Patients

NCT04219735 | Completed Phase 2

• 1 other identifier: MinoDelirium
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).

Conditions

Delirium; Coma

Keywords

delirium; minocycline; intensive care unit

Outcome Measures

Primary Outcomes (1)

• Delirium and subsyndromal delirium incidence during ICU stay

  Number of patients with delirium

  up to 28 days

Secondary Outcomes (11)

• Days in delirium during ICU stay

  up to 28 days

• Coma-delirium free days during ICU stay

  up to 28 days

• Length of mechanical ventilation during ICU stay

  up to 28 days

• Length of ICU stay

  up to 28 days

• ICU mortality

  up to 28 days

Study Arms (2)

Minocycline

EXPERIMENTAL

Minocycline 100 mg BID

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

Placebo capsules identical to experimental arm

Drug: Placebos

Interventions

Minocycline DRUG

Minocycline 100mg BID

Minocycline

Placebos DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical or surgical patients,
• Over 18 years,
• Expected ICU stay of at least 2 days estimated by the attending intensivist,
• Agree to participate in the study

You may not qualify if:

• Diagnosis of Parkinson's disease
• Diagnosis of dementia,
• Alcohol abuse history,
• Acute neurological condition at admission
• History of psychiatric disease
• Use of antipsychotics
• Pregnant or breastfeeding women,
• Expectation of death within 2 days
• Hospitalized for exclusive palliative care
• Known allergy to minocycline

Sponsors & Collaborators

• Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude: lead

Study Sites (1)

São José Hospital

Criciúma, Santa Catarina, 88801250, Brazil

Location

Related Publications (1)

• Dal-Pizzol F, Coelho A, Simon CS, Michels M, Corneo E, Jeremias A, Damasio D, Ritter C. Prophylactic Minocycline for Delirium in Critically Ill Patients: A Randomized Controlled Trial. Chest. 2024 May;165(5):1129-1138. doi: 10.1016/j.chest.2023.11.041. Epub 2023 Dec 1.

  PMID: 38043911 DERIVED

MeSH Terms

Conditions

Delirium; Coma; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Unconsciousness; Consciousness Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo capsules looking identical to minocycline capsules
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Intensive Care Unit, São José Hospital. Head, Pathophysiology Laboratory, Universidade do Extremo Sul Catarinense

Model Details: Placebo vs minocycline

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: January 7, 2020
• Study Start: January 30, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

BR (1)