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Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor (BRASS-ICU)

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ClinicalTrials.gov Identifier: NCT03835091
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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.

Deep sedation can be associated with increased mortality, lenght 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.

We think that BRASS score isn't associated with the medication used for sedation.

In our study we 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.


Condition or disease Intervention/treatment
Brainstem Response Other: BRASS score

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, lenght 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.

We think that BRASS score isn't associated with the medication used for sedation.

In our study we 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, 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 CAM-ICU, the length stay in ICU, death at day 28 and 90 will be reported.


Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Group/Cohort Intervention/treatment
Patient with mechanical ventilation and sedation
All patient hospitalized in intensive care under sedation and mechanical ventilation without neurologic disorder
Other: BRASS score
Brainstem response on neurologic examination




Primary Outcome Measures :
  1. mortality within 28 days after ICU admission [ Time Frame: 28 days ]
    percentage of patients who died within 28 days after admission


Secondary Outcome Measures :
  1. mortality within 90 days after ICU admission [ Time Frame: 90 days ]
    percentage of patients who died within 90 days after admission

  2. ICU Stay [ Time Frame: 6 months ]
    mean of duration of ICU stay

  3. Delirium [ Time Frame: 6 months ]
    percentage of patients with delirium

  4. duration on mechanical ventilation [ Time Frame: 6 months ]
    mean of duration of mechanical ventilation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who will be included in this study are patients with sedation and on mechanical ventilation, without neurologic disorder
Criteria

Inclusion Criteria:

Patient more than 18 years Hospitalized in ICU Without neurologic disorder and/or neurologic pattern Under sedation and mechanical ventilation

Exclusion Criteria:

Patients with legal protection No affiliation with the French Health Care system Ongoing pregnancy Inability to obtain consent Not to resuscitate decision Neurologic disorder


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835091


Contacts
Contact: Vincent LEGROS 3 26 78 30 21 ext 0033 vlegros@chu-reims.fr

Locations
France
Chu Reims Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03835091     History of Changes
Other Study ID Numbers: PO18167
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes