Clinical trial NCT04219735: Effect of Minocycline on Delirium Incidence in Critically Ill Patients
Official title: Effect of Minocycline on Delirium Incidence in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Coma
Keywords: delirium
minocycline
intensive care unit
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo vs minocycline
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Delirium and subsyndromal delirium incidence during ICU stay
timeFrame: up to 28 days
Secondary outcomes:
measure: Days in delirium during ICU stay
timeFrame: up to 28 days
measure: Coma-delirium free days during ICU stay
timeFrame: up to 28 days
measure: Length of mechanical ventilation during ICU stay
timeFrame: up to 28 days
measure: Length of ICU stay
timeFrame: up to 28 days
measure: ICU mortality
timeFrame: up to 28 days
measure: Hospital mortality
timeFrame: up to 90 days
measure: Long-term quality of life measured by the 12-Item Short-Form Health Survey V2
timeFrame: until 12 months after hospital discharge
measure: Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score
timeFrame: until 12 months after hospital discharge
measure: Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B
timeFrame: At Day 1 and 3 of ICU stay, and hospital discharge
measure: Long-term Post-Traumatic Stress Disorder measured by Impact of Event Scale-Revised
timeFrame: until 12 months after hospital discharge
measure: Long-term depression and anxiety symptoms measured by Hospital Anxiety and Depression Scale
timeFrame: until 12 months after hospital discharge
Other outcomes:
Locations:
city: Criciuma
country: Brazil
facility: São José Hospital
state: SC
Study officials:
References: