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Completed

NCT Number: NCT04219735

Effect of Minocycline on Delirium Incidence in Critically Ill Patients

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

São José Hospital

Criciúma, Santa Catarina, 88801250, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Delirium prior to inclusion,
  • 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

Treatment and study plan

Minocycline

Drug

Minocycline 100mg BID

Placebos

Drug

Placebo

Primary outcomes

  1. Delirium and subsyndromal delirium incidence during ICU stay

    Time frame: up to 28 days

    Number of patients with delirium

Secondary outcomes

  1. Days in delirium during ICU stay

    Time frame: up to 28 days

    Number of days being in delirium

  2. Coma-delirium free days during ICU stay

    Time frame: up to 28 days

    Number of days free of coma or delirium

  3. Length of mechanical ventilation during ICU stay

    Time frame: up to 28 days

    Number of days in mechanical ventilation

  4. Length of ICU stay

    Time frame: up to 28 days

    Number of days in the ICU

  5. ICU mortality

    Time frame: up to 28 days

    Number of dead during ICU stay

  6. Hospital mortality

    Time frame: up to 90 days

    Number of dead during hospital stay

  7. Long-term quality of life measured by the 12-Item Short-Form Health Survey V2

    Time frame: until 12 months after hospital discharge

    Quality of life measured after hospital discharge

  8. Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score

    Time frame: until 12 months after hospital discharge

    Cognitive function after hospital discharge

  9. Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B

    Time frame: At Day 1 and 3 of ICU stay, and hospital discharge

    Inflammatory and brain derived plasma biomarker levels

  10. Long-term Post-Traumatic Stress Disorder measured by Impact of Event Scale-Revised

    Time frame: until 12 months after hospital discharge

    Post-Traumatic Stress Disorder symptoms after hospital discharge measured by the Impact of Event Scale-Revised ranging from 0 to 88, higher values indicate more severe symptoms

  11. Long-term depression and anxiety symptoms measured by Hospital Anxiety and Depression Scale

    Time frame: until 12 months after hospital discharge

    Depression and anxiety symptoms after hospital discharge measured by Hospital Anxiety and Depression Scale, ranging from 0 to 21, higher values indicate more severe symptoms

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2020
Registry last updated
May 31, 2022

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

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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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