<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01707680</url>
  </required_header>
  <id_info>
    <org_study_id>3005022</org_study_id>
    <secondary_id>Dnr 2012/628-31/4</secondary_id>
    <nct_id>NCT01707680</nct_id>
  </id_info>
  <brief_title>Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients</brief_title>
  <acronym>NICEWEAN</acronym>
  <official_title>Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the use of different sedatives affect the&#xD;
      weaning process from mechanical ventilation in intensive care patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditionally patients with ongoing mechanical ventilation have been sedated to assure&#xD;
      absence of pain, anxiety and to provide comfort. Unfortunately this approach might have&#xD;
      negative consequences such as prolonged time for mechanical ventilation, length of stay in&#xD;
      the ICU and hospital.&#xD;
&#xD;
      In this study, the investigators would like to investigate (in an exploratory way due to the&#xD;
      non-interventional setup) whether weaning from mechanical ventilation will be affected by the&#xD;
      choice of sedatives - including dexmedetomidine, midazolam and propofol. This study also aims&#xD;
      at investigating how the choice of primary sedative will affect delirium/anxiety, need of&#xD;
      other medications (sedatives, analgesics, anti-psychotics), quality of life after ICU and the&#xD;
      presence of Post-Traumatic Stress Disorder. In addition, the investigators aim at receiving&#xD;
      information from the caregivers on their ICU experience, as recent data imply that not only&#xD;
      the ICU patient but also the caregiver suffer from PTSD after the ICU stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Halted due to slow recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">November 1, 2015</completion_date>
  <primary_completion_date type="Actual">November 1, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The time point from when the patient is considered &quot;fit for weaning&quot; to the actual time point for extubation</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-point for patient being considered &quot;fit for extubation&quot;</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total time in mechanical ventilation</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation failure (re-intubation within 24 hours)</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety/delirium assessments</measure>
    <time_frame>30 days</time_frame>
    <description>RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay (actual time of discharge)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL (15D)</measure>
    <time_frame>2-4 months post-ICU discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire</measure>
    <time_frame>2-4 months post-ICU discharge</time_frame>
    <description>This assessment will be offered to the ICU patients but also to their caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total duration of sedation</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days using opioids</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days using antipsychotic/neuroleptic drugs</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">155</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <description>Here, patients to be included are those being sedated with dexmedetomidine as primary sedative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <description>Here, patients to be included are those being sedated with propofol as primary sedative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <description>Here, patients to be included are those being sedated with midazolam as primary sedative</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SOC</intervention_name>
    <description>Patient are given standard of care</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult general intensive care patients Need of mechanical ventilation &gt;24 hours Need of&#xD;
        light to moderate sedation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to a general ICU ward&#xD;
&#xD;
          -  ≥ 18years&#xD;
&#xD;
          -  Intubated and mechanically ventilated for at least 24 hours&#xD;
&#xD;
          -  Need of light to moderate sedation (corresponding to RASS 0 - (-3) or MAAS 2-3)&#xD;
&#xD;
          -  Sedated with dexmedetomidine, midazolam and/or propofol&#xD;
&#xD;
          -  Good knowledge in Swedish language&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Lack of fulfilling prescribed sedation regime&#xD;
&#xD;
          -  Estimated high risk of death during the study period, according to investigator&#xD;
             (roughly equal to estimated mortality rate (EMR) &gt; 80% )&#xD;
&#xD;
          -  Tracheotomy&#xD;
&#xD;
          -  Change in sedative drugs since the &quot;fit for weaning&quot; time point&#xD;
&#xD;
          -  Use of other alpha-2 agonists (clonidine) during ICU stay&#xD;
&#xD;
          -  Positive pregnancy test or currently lactating/ known pregnancy or lactation&#xD;
&#xD;
          -  Participation in other study involving use of a pharmacologically active compound&#xD;
&#xD;
          -  Patients with limitations in therapy&#xD;
&#xD;
          -  Otherwise unable to fulfill the study, according to investigator's opinion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl-Johan Wickerts, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danderyds Hospital, Danderyd, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danderyds Hospital Anestesi- och intensivvårdskliniken</name>
      <address>
        <city>Danderyd</city>
        <zip>SE18288</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capio S:t Goran Hospital, Anestesikliniken</name>
      <address>
        <city>Stockholm</city>
        <zip>SE11281</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Örebro University Hospital, Anestesi- och intensivvårdskliniken</name>
      <address>
        <city>Örebro</city>
        <zip>SE70185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <results_reference>
    <citation>Nunes SL, Forsberg S, Blomqvist H, Berggren L, Sorberg M, Sarapohja T, Wickerts CJ. Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit. Clin Drug Investig. 2018 Jun;38(6):535-543. doi: 10.1007/s40261-018-0636-2.</citation>
    <PMID>29502195</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>weaning</keyword>
  <keyword>mechanical ventilation</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>propofol</keyword>
  <keyword>midazolam</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01707680
org study id: 3005022
secondary id: Dnr 2012/628-31/4
nct id: NCT01707680
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether the use of different sedatives affect the
      weaning process from mechanical ventilation in intensive care patients.
Traditionally patients with ongoing mechanical ventilation have been sedated to assure
      absence of pain, anxiety and to provide comfort. Unfortunately this approach might have
      negative consequences such as prolonged time for mechanical ventilation, length of stay in
      the ICU and hospital.

      In this study, the investigators would like to investigate (in an exploratory way due to the
      non-interventional setup) whether weaning from mechanical ventilation will be affected by the
      choice of sedatives - including dexmedetomidine, midazolam and propofol. This study also aims
      at investigating how the choice of primary sedative will affect delirium/anxiety, need of
      other medications (sedatives, analgesics, anti-psychotics), quality of life after ICU and the
      presence of Post-Traumatic Stress Disorder. In addition, the investigators aim at receiving
      information from the caregivers on their ICU experience, as recent data imply that not only
      the ICU patient but also the caregiver suffer from PTSD after the ICU stay.
observational model: Cohort
time perspective: Retrospective
measure: The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
time frame: 30 days
measure: Time-point for patient being considered "fit for extubation"
time frame: 30 days
measure: Total time in mechanical ventilation
time frame: 30 days
measure: Extubation failure (re-intubation within 24 hours)
time frame: 24 hours
measure: Anxiety/delirium assessments
time frame: 30 days
description: RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate
measure: Length of ICU stay (actual time of discharge)
time frame: 30 days
measure: QoL (15D)
time frame: 2-4 months post-ICU discharge
measure: Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire
time frame: 2-4 months post-ICU discharge
description: This assessment will be offered to the ICU patients but also to their caregivers.
measure: Total duration of sedation
time frame: 30 days
measure: Number of days using opioids
time frame: 30 days
measure: Number of days using antipsychotic/neuroleptic drugs
time frame: 30 days
arm group label: Dexmedetomidine
description: Here, patients to be included are those being sedated with dexmedetomidine as primary sedative.
arm group label: Propofol
description: Here, patients to be included are those being sedated with propofol as primary sedative.
arm group label: Midazolam
description: Here, patients to be included are those being sedated with midazolam as primary sedative
intervention type: Other
intervention name: SOC
description: Patient are given standard of care
arm group label: Dexmedetomidine
arm group label: Midazolam
arm group label: Propofol
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carl-Johan Wickerts, MD
role: Principal Investigator
affiliation: Danderyds Hospital, Danderyd, Sweden
facility: 
facility: 
facility: 
country: Sweden
citation: Nunes SL, Forsberg S, Blomqvist H, Berggren L, Sorberg M, Sarapohja T, Wickerts CJ. Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit. Clin Drug Investig. 2018 Jun;38(6):535-543. doi: 10.1007/s40261-018-0636-2.
PMID: 29502195
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No