Effect of Minocycline on Delirium Incidence in Critically Ill Patients

Delirium Clinical Trial

Official title:

Effect of Minocycline on Delirium Incidence in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219735
• Other study ID #: MinoDelirium
• Status: Completed
• Phase: Phase 2
• Start date: January 30, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2022
• Source: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coma
• Delirium

Intervention

Drug:
• Minocycline
Minocycline 100mg BID
• Placebos
Placebo

Locations

Country	Name	City	State
Brazil	São José Hospital	Criciuma	SC

Sponsors (1)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium and subsyndromal delirium incidence during ICU stay	Number of patients with delirium	up to 28 days
Secondary	Days in delirium during ICU stay	Number of days being in delirium	up to 28 days
Secondary	Coma-delirium free days during ICU stay	Number of days free of coma or delirium	up to 28 days
Secondary	Length of mechanical ventilation during ICU stay	Number of days in mechanical ventilation	up to 28 days
Secondary	Length of ICU stay	Number of days in the ICU	up to 28 days
Secondary	ICU mortality	Number of dead during ICU stay	up to 28 days
Secondary	Hospital mortality	Number of dead during hospital stay	up to 90 days
Secondary	Long-term quality of life measured by the 12-Item Short-Form Health Survey V2	Quality of life measured after hospital discharge	until 12 months after hospital discharge
Secondary	Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score	Cognitive function after hospital discharge	until 12 months after hospital discharge
Secondary	Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B	Inflammatory and brain derived plasma biomarker levels	At Day 1 and 3 of ICU stay, and hospital discharge
Secondary	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	until 12 months after hospital discharge
Secondary	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	until 12 months after hospital discharge