Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT04219735
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Minocycline on Delirium Incidence in Critically Ill Patients
Sponsor:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Organization:
Study Overview
Official Title:
Effect of Minocycline on Delirium Incidence in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: