Effect of Minocycline on Delirium Incidence in Critically Ill Patients
Status:
Recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude