search
Back to results

Effect of Minocycline on Delirium Incidence in Critically Ill Patients

Primary Purpose

Delirium, Coma

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Minocycline
Placebos
Sponsored by
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring delirium, minocycline, intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • São José Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Minocycline

Placebo

Arm Description

Minocycline 100 mg BID

Placebo capsules identical to experimental arm

Outcomes

Primary Outcome Measures

Delirium and subsyndromal delirium incidence during ICU stay
Number of patients with delirium

Secondary Outcome Measures

Days in delirium during ICU stay
Number of days being in delirium
Coma-delirium free days during ICU stay
Number of days free of coma or delirium
Length of mechanical ventilation during ICU stay
Number of days in mechanical ventilation
Length of ICU stay
Number of days in the ICU
ICU mortality
Number of dead during ICU stay
Hospital mortality
Number of dead during hospital stay
Long-term quality of life measured by the 12-Item Short-Form Health Survey V2
Quality of life measured after hospital discharge
Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score
Cognitive function after hospital discharge
Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B
Inflammatory and brain derived plasma biomarker levels
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
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

Full Information

First Posted
October 29, 2019
Last Updated
May 26, 2022
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
search

1. Study Identification

Unique Protocol Identification Number
NCT04219735
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Coma
Keywords
delirium, minocycline, intensive care unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo vs minocycline
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo capsules looking identical to minocycline capsules
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline
Arm Type
Experimental
Arm Description
Minocycline 100 mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules identical to experimental arm
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
Minocycline 100mg BID
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Delirium and subsyndromal delirium incidence during ICU stay
Description
Number of patients with delirium
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Days in delirium during ICU stay
Description
Number of days being in delirium
Time Frame
up to 28 days
Title
Coma-delirium free days during ICU stay
Description
Number of days free of coma or delirium
Time Frame
up to 28 days
Title
Length of mechanical ventilation during ICU stay
Description
Number of days in mechanical ventilation
Time Frame
up to 28 days
Title
Length of ICU stay
Description
Number of days in the ICU
Time Frame
up to 28 days
Title
ICU mortality
Description
Number of dead during ICU stay
Time Frame
up to 28 days
Title
Hospital mortality
Description
Number of dead during hospital stay
Time Frame
up to 90 days
Title
Long-term quality of life measured by the 12-Item Short-Form Health Survey V2
Description
Quality of life measured after hospital discharge
Time Frame
until 12 months after hospital discharge
Title
Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score
Description
Cognitive function after hospital discharge
Time Frame
until 12 months after hospital discharge
Title
Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B
Description
Inflammatory and brain derived plasma biomarker levels
Time Frame
At Day 1 and 3 of ICU stay, and hospital discharge
Title
Long-term Post-Traumatic Stress Disorder measured by Impact of Event Scale-Revised
Description
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
Title
Long-term depression and anxiety symptoms measured by Hospital Anxiety and Depression Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
São José Hospital
City
Criciuma
State/Province
SC
ZIP/Postal Code
88801250
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effect of Minocycline on Delirium Incidence in Critically Ill Patients

We'll reach out to this number within 24 hrs