<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/NCT04422808</url>
  </required_header>
  <id_info>
    <org_study_id>116</org_study_id>
    <nct_id>NCT04422808</nct_id>
  </id_info>
  <brief_title>AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU)</brief_title>
  <official_title>Assessing Current Analgesia and Sedation Weaning Practices in Adult Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wilkes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wilkes University</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>
      Withdrawal from opioids and sedatives administered for medical purposes (i.e. iatrogenic&#xD;
      withdrawal) often goes unrecognized in the critically ill, but its prevalence is high.&#xD;
      Reports describing what is being implemented at the bedside to prevent iatrogenic withdrawal&#xD;
      are lacking, and how patients are monitored and assessed for withdrawal has not been&#xD;
      adequately studied. Therefore, the investigators overall objective is to determine the&#xD;
      current analgesia and sedation weaning practices in adult ICUs. In order to accomplish this&#xD;
      objective the investigators plan to conduct a prospective, observational, point prevalence&#xD;
      trial. Data from this project will help support future investigation of iatrogenic&#xD;
      withdrawal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design for this study will be an international, prospective, observational, point&#xD;
      prevalence trial. The investigators plan to recruit multiple sites to participate in the&#xD;
      study through the use of professional organization list serves as well as direct outreach to&#xD;
      colleagues and associates of members of the investigator team. Data collection will be&#xD;
      performed by site investigators on one single day for all patients currently in the ICU who&#xD;
      meet inclusion criteria on the data collection day. Site investigators will have an&#xD;
      approximately three-month time frame in which to choose a data collection date. All data&#xD;
      collection will be performed using REDcap, a secure web-based data collection tool that meets&#xD;
      the HIPAA (Health Insurance Portability and Accountability Act of 1996) requirements for&#xD;
      protection of patient health information. Utilization of this system will allow real-time&#xD;
      input of data from the patient's bedside by site investigators. Data collected will include&#xD;
      various site and patient demographic data. The investigators will also collect opioid and&#xD;
      sedative doses, durations of therapy, weaning of doses, and withdrawal assessment results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number patients weaned from parenteral analgesics</measure>
    <time_frame>Three months</time_frame>
    <description>The primary outcome will be the number of patients who are weaned from continuous parenteral analgesics and sedatives using a standardized approach. Continuous analgesic and sedative administration will be defined as those given as a continuous intravenous infusion, scheduled intermittent intravenous or subcutaneous injections, or as needed with at least half of the possible doses in a 24 hour period being administered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient proportion</measure>
    <time_frame>Three months</time_frame>
    <description>Proportion of ICU patients who are receiving continuous analgesics and sedatives</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utilized analgesic and sedative weaning practice</measure>
    <time_frame>three months</time_frame>
    <description>Types of analgesic and sedative weaning practices being utilized in adult ICU patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients assessed</measure>
    <time_frame>three months</time_frame>
    <description>Number of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment tools</measure>
    <time_frame>three months</time_frame>
    <description>Assessment tools being utilized for iatrogenic withdrawal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standardized approach patients</measure>
    <time_frame>three months</time_frame>
    <description>Number of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized.</description>
  </secondary_outcome>
  <enrollment type="Actual">2437</enrollment>
  <condition>Withdrawal Syndrome</condition>
  <condition>Iatrogenic Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We anticipate the involvement of at least 50 intensive care unit centers within the United&#xD;
        States, and less than 10 sites outside the United States (primarily in Canada, Australia,&#xD;
        Europe, and the Middle East). Estimating an average of 10 patients who meet study criteria&#xD;
        at each site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients 18 years and older admitted to an adult intensive care unit on the day of&#xD;
             data collection who have received parenteral analgesics or sedatives in the previous&#xD;
             24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have not received parenteral analgesics or sedatives in the previous 24&#xD;
             hours.&#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>Gilles L Fraser, PharmD, MCCM</last_name>
    <role>Study Director</role>
    <affiliation>Tufts University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Bolesta, PharmD, BCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wilkes University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc M Perreault, MSc, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Burry, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian L Erstad, PharmD, MCCM</last_name>
    <role>Study Director</role>
    <affiliation>The University of Arizona College of Pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Céline Gélinas, N., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Ingram School of Nursing</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard R Riker, MD, FCCM</last_name>
    <role>Study Director</role>
    <affiliation>Tufts University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katrianna D Saltarelli, Student</last_name>
    <role>Study Chair</role>
    <affiliation>Wilkes University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Mitchell, Student</last_name>
    <role>Study Chair</role>
    <affiliation>Wilkes University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kathryn E Smith, PharmD, BCPS, BCCCP</last_name>
    <role>Study Director</role>
    <affiliation>MaineHealth</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Federico Carini, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Italiano de Buenos Aires</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rebekah Eadie, MPharm, MSc, IP, MPSNI</last_name>
    <role>Study Director</role>
    <affiliation>Ulster Hospital- South Eastern Health and Social Care Board</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jamie Harpel, Student</last_name>
    <role>Study Chair</role>
    <affiliation>Wilkes University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ryan Stewart, Student</last_name>
    <role>Study Chair</role>
    <affiliation>Wilkes University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wilkes University</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18701-1013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Borkowska M, Labeau S, Schepens T, Vandijck D, Van de Vyver K, Christiaens D, Lizy C, Blackwood B, Blot SI. Nurses' Sedation Practices During Weaning of Adults From Mechanical Ventilation in an Intensive Care Unit. Am J Crit Care. 2018 Jan;27(1):32-42. doi: 10.4037/ajcc2018959.</citation>
    <PMID>29292273</PMID>
  </results_reference>
  <results_reference>
    <citation>Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1.</citation>
    <PMID>10776874</PMID>
  </results_reference>
  <results_reference>
    <citation>Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015.</citation>
    <PMID>9559604</PMID>
  </results_reference>
  <results_reference>
    <citation>Chiu AW, Contreras S, Mehta S, Korman J, Perreault MM, Williamson DR, Burry LD. Iatrogenic Opioid Withdrawal in Critically Ill Patients: A Review of Assessment Tools and Management. Ann Pharmacother. 2017 Dec;51(12):1099-1111. doi: 10.1177/1060028017724538. Epub 2017 Aug 9.</citation>
    <PMID>28793780</PMID>
  </results_reference>
  <results_reference>
    <citation>Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399.</citation>
    <PMID>25602358</PMID>
  </results_reference>
  <results_reference>
    <citation>Duceppe MA, Perreault MM, Frenette AJ, Burry LD, Rico P, Lavoie A, Gelinas C, Mehta S, Dagenais M, Williamson DR. Frequency, risk factors and symptomatology of iatrogenic withdrawal from opioids and benzodiazepines in critically Ill neonates, children and adults: A systematic review of clinical studies. J Clin Pharm Ther. 2019 Apr;44(2):148-156. doi: 10.1111/jcpt.12787. Epub 2018 Dec 19.</citation>
    <PMID>30569508</PMID>
  </results_reference>
  <results_reference>
    <citation>Fonsmark L, Rasmussen YH, Carl P. Occurrence of withdrawal in critically ill sedated children. Crit Care Med. 1999 Jan;27(1):196-9. doi: 10.1097/00003246-199901000-00052.</citation>
    <PMID>9934916</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5.</citation>
    <PMID>28866754</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wilkes University</investigator_affiliation>
    <investigator_full_name>Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Opioid withdrawal</keyword>
  <keyword>Benzodiazepine withdrawal</keyword>
  <keyword>Narcotic withdrawal</keyword>
  <keyword>Critically ill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iatrogenic Disease</mesh_term>
    <mesh_term>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Plan is to share individual participant data specific to each institution through data access groups in RedCap</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Twelve months after data collection completed.</ipd_time_frame>
    <ipd_access_criteria>Individual site data will be accessible to each specific participating study site. Only site investigators will have access to their study site data.</ipd_access_criteria>
  </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/NCT04422808
org study id: 116
nct id: NCT04422808
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Withdrawal from opioids and sedatives administered for medical purposes (i.e. iatrogenic
      withdrawal) often goes unrecognized in the critically ill, but its prevalence is high.
      Reports describing what is being implemented at the bedside to prevent iatrogenic withdrawal
      are lacking, and how patients are monitored and assessed for withdrawal has not been
      adequately studied. Therefore, the investigators overall objective is to determine the
      current analgesia and sedation weaning practices in adult ICUs. In order to accomplish this
      objective the investigators plan to conduct a prospective, observational, point prevalence
      trial. Data from this project will help support future investigation of iatrogenic
      withdrawal.
The design for this study will be an international, prospective, observational, point
      prevalence trial. The investigators plan to recruit multiple sites to participate in the
      study through the use of professional organization list serves as well as direct outreach to
      colleagues and associates of members of the investigator team. Data collection will be
      performed by site investigators on one single day for all patients currently in the ICU who
      meet inclusion criteria on the data collection day. Site investigators will have an
      approximately three-month time frame in which to choose a data collection date. All data
      collection will be performed using REDcap, a secure web-based data collection tool that meets
      the HIPAA (Health Insurance Portability and Accountability Act of 1996) requirements for
      protection of patient health information. Utilization of this system will allow real-time
      input of data from the patient's bedside by site investigators. Data collected will include
      various site and patient demographic data. The investigators will also collect opioid and
      sedative doses, durations of therapy, weaning of doses, and withdrawal assessment results.
observational model: Other
time perspective: Prospective
measure: Number patients weaned from parenteral analgesics
time frame: Three months
description: The primary outcome will be the number of patients who are weaned from continuous parenteral analgesics and sedatives using a standardized approach. Continuous analgesic and sedative administration will be defined as those given as a continuous intravenous infusion, scheduled intermittent intravenous or subcutaneous injections, or as needed with at least half of the possible doses in a 24 hour period being administered.
measure: Patient proportion
time frame: Three months
description: Proportion of ICU patients who are receiving continuous analgesics and sedatives
measure: Utilized analgesic and sedative weaning practice
time frame: three months
description: Types of analgesic and sedative weaning practices being utilized in adult ICU patients.
measure: Number of patients assessed
time frame: three months
description: Number of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives.
measure: Assessment tools
time frame: three months
description: Assessment tools being utilized for iatrogenic withdrawal.
measure: Standardized approach patients
time frame: three months
description: Number of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles L Fraser, PharmD, MCCM
role: Study Director
affiliation: Tufts University School of Medicine
last name: Scott Bolesta, PharmD, BCPS
role: Principal Investigator
affiliation: Wilkes University
last name: Marc M Perreault, MSc, PharmD
role: Study Director
affiliation: Université de Montréal
last name: Lisa Burry, PharmD
role: Study Director
affiliation: MOUNT SINAI HOSPITAL
last name: Brian L Erstad, PharmD, MCCM
role: Study Director
affiliation: The University of Arizona College of Pharmacy
last name: Céline Gélinas, N., Ph.D.
role: Study Director
affiliation: Ingram School of Nursing
last name: Richard R Riker, MD, FCCM
role: Study Director
affiliation: Tufts University School of Medicine
last name: Katrianna D Saltarelli, Student
role: Study Chair
affiliation: Wilkes University
last name: Jennifer Mitchell, Student
role: Study Chair
affiliation: Wilkes University
last name: Kathryn E Smith, PharmD, BCPS, BCCCP
role: Study Director
affiliation: MaineHealth
last name: Federico Carini, MD
role: Study Director
affiliation: Hospital Italiano de Buenos Aires
last name: Rebekah Eadie, MPharm, MSc, IP, MPSNI
role: Study Director
affiliation: Ulster Hospital- South Eastern Health and Social Care Board
last name: Jamie Harpel, Student
role: Study Chair
affiliation: Wilkes University
last name: Ryan Stewart, Student
role: Study Chair
affiliation: Wilkes University
facility: 
country: United States
citation: Borkowska M, Labeau S, Schepens T, Vandijck D, Van de Vyver K, Christiaens D, Lizy C, Blackwood B, Blot SI. Nurses' Sedation Practices During Weaning of Adults From Mechanical Ventilation in an Intensive Care Unit. Am J Crit Care. 2018 Jan;27(1):32-42. doi: 10.4037/ajcc2018959.
PMID: 29292273
citation: Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1.
PMID: 10776874
citation: Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015.
PMID: 9559604
citation: Chiu AW, Contreras S, Mehta S, Korman J, Perreault MM, Williamson DR, Burry LD. Iatrogenic Opioid Withdrawal in Critically Ill Patients: A Review of Assessment Tools and Management. Ann Pharmacother. 2017 Dec;51(12):1099-1111. doi: 10.1177/1060028017724538. Epub 2017 Aug 9.
PMID: 28793780
citation: Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399.
PMID: 25602358
citation: Duceppe MA, Perreault MM, Frenette AJ, Burry LD, Rico P, Lavoie A, Gelinas C, Mehta S, Dagenais M, Williamson DR. Frequency, risk factors and symptomatology of iatrogenic withdrawal from opioids and benzodiazepines in critically Ill neonates, children and adults: A systematic review of clinical studies. J Clin Pharm Ther. 2019 Apr;44(2):148-156. doi: 10.1111/jcpt.12787. Epub 2018 Dec 19.
PMID: 30569508
citation: Fonsmark L, Rasmussen YH, Carl P. Occurrence of withdrawal in critically ill sedated children. Crit Care Med. 1999 Jan;27(1):196-9. doi: 10.1097/00003246-199901000-00052.
PMID: 9934916
citation: Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5.
PMID: 28866754
responsible party type: Principal Investigator
investigator affiliation: Wilkes University
investigator full name: Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP
investigator title: Associate Professor
mesh term: Iatrogenic Disease
mesh term: Substance Withdrawal Syndrome
sharing ipd: Yes
ipd description: Plan is to share individual participant data specific to each institution through data access groups in RedCap
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Twelve months after data collection completed.
ipd access criteria: Individual site data will be accessible to each specific participating study site. Only site investigators will have access to their study site data.