DeliriumPhase 2NCT04219735
Effect of Minocycline on Delirium Incidence in Critically Ill Patients
A Phase 2 study testing Minocycline in people with Delirium and Coma, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2020to 30 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Delirium prior to inclusion,
- Diagnosis of Parkinson's disease
- Diagnosis of dementia,
- Alcohol abuse history,
- Acute neurological condition at admission
- History of psychiatric disease
Show all 11Show fewer
- Use of antipsychotics
- Pregnant or breastfeeding women,
- Expectation of death within 2 days
- Hospitalized for exclusive palliative care
- Known allergy to minocycline
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Minocycline, Placebos
- Keywords
- delirium, minocycline, intensive care unit
- Medical subject headings
- Delirium, Coma, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Minocycline 100mg BID
PlacebosDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Minocycline 100 mg BID Receives: Drug: Minocycline |
| Placebo | Placebo comparator | Placebo capsules identical to experimental arm Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium and subsyndromal delirium incidence during ICU stay
Number of patients with delirium
Measured: up to 28 days
Secondary outcomes (11)
Days in delirium during ICU stay
Number of days being in delirium
Measured: up to 28 days
Coma-delirium free days during ICU stay
Number of days free of coma or delirium
Measured: up to 28 days
Length of mechanical ventilation during ICU stay
Number of days in mechanical ventilation
Measured: up to 28 days
Length of ICU stay
Number of days in the ICU
Measured: up to 28 days
ICU mortality
Number of dead during ICU stay
Measured: up to 28 days
Hospital mortality
Number of dead during hospital stay
Measured: up to 90 days
Long-term quality of life measured by the 12-Item Short-Form Health Survey V2
Quality of life measured after hospital discharge
Measured: until 12 months after hospital discharge
Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score
Cognitive function after hospital discharge
Measured: until 12 months after hospital discharge
Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B
Inflammatory and brain derived plasma biomarker levels
Measured: At Day 1 and 3 of ICU stay, and hospital discharge
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
Measured: until 12 months after hospital discharge
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
Measured: until 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start30 Jan 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo vs minocycline
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219735
- Sponsor's protocol ID
- MinoDelirium
- Status last verified
- May 2022
- First submitted
- 29 Oct 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dal-Pizzol F, Coelho A, Simon CS, Michels M, Corneo E, Jeremias A, Damasio D, Ritter C. Prophylactic Minocycline for Delirium in Critically Ill Patients: A Randomized Controlled Trial. Chest. 2024 May;165(5):1129-1138. doi: 10.1016/j.chest.2023.11.041. Epub 2023 Dec 1.
PubMed 38043911
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minocycline on Delirium Incidence in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04219735
- Acronym / sponsor ID
- MinoDelirium
- Keywords
- delirium, minocycline, intensive care unit
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo vs minocycline
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineMinocycline 100 mg BID |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo capsules identical to experimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Delirium prior to inclusion,
- Diagnosis of Parkinson's disease
- Diagnosis of dementia,
- Alcohol abuse history,
- Acute neurological condition at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineMinocycline 100mg BID | Drug | Minocycline |
| PlacebosPlacebo | Drug | Placebo |
Primary outcome
Delirium and subsyndromal delirium incidence during ICU stay
Time frame: up to 28 days
Number of patients with delirium
11 secondary outcomes
Days in delirium during ICU stay
Time frame: up to 28 days
Coma-delirium free days during ICU stay
Time frame: up to 28 days
Length of mechanical ventilation during ICU stay
Time frame: up to 28 days
Length of ICU stay
Time frame: up to 28 days
ICU mortality
Time frame: up to 28 days
Hospital mortality
Time frame: up to 90 days
Long-term quality of life measured by the 12-Item Short-Form Health Survey V2
Time frame: until 12 months after hospital discharge
Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score
Time frame: until 12 months after hospital discharge
Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B
Time frame: At Day 1 and 3 of ICU stay, and hospital discharge
Long-term Post-Traumatic Stress Disorder measured by Impact of Event Scale-Revised
Time frame: until 12 months after hospital discharge
Long-term depression and anxiety symptoms measured by Hospital Anxiety and Depression Scale
Time frame: until 12 months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 38043911Dal-Pizzol F, Coelho A, Simon CS, Michels M, Corneo E, Jeremias A, Damasio D, Ritter C. Prophylactic Minocycline for Delirium in Critically Ill Patients: A Randomized Controlled Trial. Chest. 2024 May;165(5):1129-1138. doi: 10.1016/j.chest.2023.11.041. Epub 2023 Dec 1.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline in people with Delirium and Coma, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium and subsyndromal delirium incidence during ICU stay (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.