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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
Minocycline 100mg BID
Placebo
São José Hospital
Criciúma, Santa Catarina, Brazil
Delirium and subsyndromal delirium incidence during ICU stay
Number of patients with delirium
Time frame: up to 28 days
Days in delirium during ICU stay
Number of days being in delirium
Time frame: up to 28 days
Coma-delirium free days during ICU stay
Number of days free of coma or delirium
Time frame: up to 28 days
Length of mechanical ventilation during ICU stay
Number of days in mechanical ventilation
Time frame: up to 28 days
Length of ICU stay
Number of days in the ICU
Time frame: up to 28 days
ICU mortality
Number of dead during ICU stay
Time frame: up to 28 days
Hospital mortality
Number of dead during hospital stay
Time frame: up to 90 days
Long-term quality of life measured by the 12-Item Short-Form Health Survey V2
Quality of life measured after hospital discharge
Time frame: until 12 months after hospital discharge
Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score
Cognitive function after hospital discharge
Time frame: until 12 months after hospital discharge
Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B
Inflammatory and brain derived plasma biomarker levels
Time frame: At Day 1 and 3 of ICU stay, and hospital discharge
Long-term Post-Traumatic Stress Disorder measured by Impact of Event Scale-Revised
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
Time frame: until 12 months after hospital discharge
Long-term depression and anxiety symptoms measured by Hospital Anxiety and Depression Scale
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
Time frame: until 12 months after hospital discharge
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