Brainstem ResponseBRASS-ICUNCT03835091
Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor
An observational study of Brainstem Response, run by CHU de Reims at 1 site in France.
Trial summary
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock. Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brainstem Response
- What is being tested?
- BRASS score
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2019to 26 Aug 2019
- Phase
- Observational
- 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
Study population: Patients who will be included in this study are patients with sedation and on mechanical ventilation, without neurologic disorder
Who may be able to join
- Patient more than 18 years Hospitalized in ICU Without neurologic disorder and/or neurologic pattern Under sedation and mechanical ventilation
Who cannot join
- Patients with legal protection No affiliation with the French Health Care system Ongoing pregnancy Inability to obtain consent Not to resuscitate decision Neurologic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock.
Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.
Read more
Deep sedation can be associated with increased mortality, length stay, duration of mechanical ventilation, acute brain dysfunction.
The french exploration neurologic group in ICU developed a score used Brainstem response patterns in patient deeply sedated by midazolam and showed that a high BRASS score is associated with high mortality at day 28.
The investigators think that BRASS score isn't associated with the medication used for sedation.
In this study the investigators included all patients sedated independently of medication used for sedation, we also excluded patient with neurologic disorder.
The main objective is to shown that high BRASS score at admission of patient without neurologic disorder sedated is predictive of 28-day mortality.
Read the detailed description
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock.
Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.
Deep sedation can be associated with increased mortality, length stay, duration of mechanical ventilation, acute brain dysfunction.
The french exploration neurologic group in ICU developed a score used Brainstem response patterns in patient deeply sedated by midazolam and showed that a high BRASS score is associated with high mortality at day 28.
The investigators think that BRASS score isn't associated with the medication used for sedation.
In this study the investigators included all patients sedated independently of medication used for sedation, we also excluded patient with neurologic disorder.
The main objective is to shown that high BRASS score at admission of patient without neurologic disorder sedated is predictive of 28-day mortality.
The BRASS score will be done in the 6 hours within admission. The Richmond Assessment Sedation Scale (RASS) and Full Outline of unresponsiveness (FOUR) will be performed.
The patient characteristic's will be recorded (sex, age, Simplified Acute Physiology Score II (SAPS II), medical or surgical admission, diagnosis at ICU admission (ARDS, sepsis,…), the reason of initiation of mechanical ventilation, the reason of sedation (agitation, analgesia, asynchrony with ventilator).
The medication for sedation and the level at time of examination, the time between admission and examination will be recorded.
For the outcome, the duration of mechanical ventilation, the duration of sedation administration, the occurrence of delirium evaluated by Confusion Assessment Method- intensive care unit (CAM-ICU), the length stay in ICU, death at day 28 and 90 will be reported.
- Conditions
- Brainstem Response
- Being tested
- BRASS score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRASS scoreOther
Brainstem response on neurologic examination
| Study group | Role | What they receive |
|---|---|---|
| Patient with mechanical ventilation and sedation | All patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder Receives: Other: BRASS score |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality within 28 days after ICU admission
percentage of patients who died within 28 days after admission
Measured: 28 days
Secondary outcomes (4)
mortality within 90 days after ICU admission
percentage of patients who died within 90 days after admission
Measured: 90 days
ICU Stay
mean of duration of ICU stay
Measured: 6 months
Delirium
percentage of patients with delirium
Measured: 6 months
duration on mechanical ventilation
mean of duration of mechanical ventilation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start7 Feb 2019
- Primary completion29 May 2019
- Study completion26 Aug 2019
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 Brainstem ResponseStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835091
- Sponsor's protocol ID
- PO18167
- Acronym
- BRASS-ICU
- Status last verified
- Mar 2020
- First submitted
- 7 Feb 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Legros V, Mourvillier B, Floch T, Candelier Q, Rosman J, Lafont B, Farkas JC, Bard M, Kanagaratnam L, Mateu P. Use of BRASS in sedated critically-ill patients as a predictable mortality factor: BRASS-ICU. Neurol Res. 2021 Apr;43(4):283-290. doi: 10.1080/01616412.2020.1849901. Epub 2020 Nov 19.
PubMed 33208055
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor
- ClinicalTrials.gov ID
- NCT03835091
- Acronym / sponsor ID
- BRASS-ICU / PO18167
- Conditions
- Brainstem Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 8 Feb 2019 (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.
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock.
Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.
Deep sedation can be associated with increased mortality, length stay, duration of mechanical ventilation, acute brain dysfunction.
The french exploration neurologic group in ICU developed a score used Brainstem response patterns in patient deeply sedated by midazolam and showed that a high BRASS score is associated with high mortality at day 28.
The investigators think that BRASS score isn't associated with the medication used for sedation.
In this study the investigators included all patients sedated independently of medication used for sedation, we also excluded patient with neurologic disorder.
The main objective is to shown that high BRASS score at admission of patient without neurologic disorder sedated is predictive of 28-day mortality.
Detailed description
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock.
Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.
Deep sedation can be associated with increased mortality, length stay, duration of mechanical ventilation, acute brain dysfunction.
The french exploration neurologic group in ICU developed a score used Brainstem response patterns in patient deeply sedated by midazolam and showed that a high BRASS score is associated with high mortality at day 28.
The investigators think that BRASS score isn't associated with the medication used for sedation.
In this study the investigators included all patients sedated independently of medication used for sedation, we also excluded patient with neurologic disorder.
The main objective is to shown that high BRASS score at admission of patient without neurologic disorder sedated is predictive of 28-day mortality.
The BRASS score will be done in the 6 hours within admission. The Richmond Assessment Sedation Scale (RASS) and Full Outline of unresponsiveness (FOUR) will be performed.
The patient characteristic's will be recorded (sex, age, Simplified Acute Physiology Score II (SAPS II), medical or surgical admission, diagnosis at ICU admission (ARDS, sepsis,…), the reason of initiation of mechanical ventilation, the reason of sedation (agitation, analgesia, asynchrony with ventilator).
The medication for sedation and the level at time of examination, the time between admission and examination will be recorded.
For the outcome, the duration of mechanical ventilation, the duration of sedation administration, the occurrence of delirium evaluated by Confusion Assessment Method- intensive care unit (CAM-ICU), the length stay in ICU, death at day 28 and 90 will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with mechanical ventilation and sedation | – | Other: BRASS scoreAll patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be included in this study are patients with sedation and on mechanical ventilation, without neurologic disorder
Key inclusion criteria (1 listed)
- Patient more than 18 years Hospitalized in ICU Without neurologic disorder and/or neurologic pattern Under sedation and mechanical ventilation
Key exclusion criteria (1 listed)
- Patients with legal protection No affiliation with the French Health Care system Ongoing pregnancy Inability to obtain consent Not to resuscitate decision Neurologic disorder
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 |
|---|---|---|
| BRASS scoreBrainstem response on neurologic examination | Other | Patient with mechanical ventilation and sedation |
Primary outcome
mortality within 28 days after ICU admission
Time frame: 28 days
percentage of patients who died within 28 days after admission
4 secondary outcomes
mortality within 90 days after ICU admission
Time frame: 90 days
ICU Stay
Time frame: 6 months
Delirium
Time frame: 6 months
duration on mechanical ventilation
Time frame: 6 months
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 23 Mar 2020.
- Derived from this study: PubMed 33208055Legros V, Mourvillier B, Floch T, Candelier Q, Rosman J, Lafont B, Farkas JC, Bard M, Kanagaratnam L, Mateu P. Use of BRASS in sedated critically-ill patients as a predictable mortality factor: BRASS-ICU. Neurol Res. 2021 Apr;43(4):283-290. doi: 10.1080/01616412.2020.1849901. Epub 2020 Nov 19.
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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?
An observational study of Brainstem Response, run by CHU de Reims at 1 site in France.
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 1 inclusion and 1 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 23 Mar 2020. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
mortality within 28 days after ICU admission (time frame: 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 NCT03835091, 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 23 Mar 2020.