<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/NCT04436224</url>
  </required_header>
  <id_info>
    <org_study_id>nfyyicu002</org_study_id>
    <nct_id>NCT04436224</nct_id>
  </id_info>
  <brief_title>Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation</brief_title>
  <official_title>Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression&#xD;
      and gastrointestinal motility. The study will further explore the continuous pumping-dose of&#xD;
      hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma&#xD;
      concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU&#xD;
      non-mechanical ventilation patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>successful analgesic proportion</measure>
    <time_frame>From date of using the intervention drugs until the date of leaving from icu, up to 28 days</time_frame>
    <description>Proportion of patients in each group who reached the target analgesia score range</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score</measure>
    <time_frame>From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days</time_frame>
    <description>analgesia score, such as CPOT or NRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dose of analgesics</measure>
    <time_frame>From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days</time_frame>
    <description>total dose of analgesics during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days</time_frame>
    <description>Adverse event during the study, including hypotension.et</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.</time_frame>
    <description>duration of stay in ICU</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">530</enrollment>
  <condition>Hydromorphone</condition>
  <condition>Analgesia</condition>
  <condition>ICU</condition>
  <arm_group>
    <arm_group_label>hydromorphone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Butorphanol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydromorphone</intervention_name>
    <description>Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)</description>
    <arm_group_label>hydromorphone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)</description>
    <arm_group_label>fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Butorphanol</intervention_name>
    <description>Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)</description>
    <arm_group_label>Butorphanol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years old;&#xD;
&#xD;
          -  Non-mechanical ventilation patients with expected ICU stay time &gt;24h&#xD;
&#xD;
          -  People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or&#xD;
             BPS ≥ 5 points, CPOT ≥ 3);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy；&#xD;
&#xD;
          -  can not get pain score from patients&#xD;
&#xD;
          -  allergy to drugs&#xD;
&#xD;
          -  ....&#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_contact>
    <last_name>Hongbin Hu, doctor</last_name>
    <phone>+8613922483752</phone>
    <email>hobewoos@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Southern medical university Nanfang hospital</name>
      <address>
        <city>Guangzhou</city>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongbin Hu, doctor</last_name>
      <phone>+8613922483752</phone>
      <email>hobewoos@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>January 19, 2022</last_update_submitted>
  <last_update_submitted_qc>January 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Zhenhua Zen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Hydromorphone</mesh_term>
    <mesh_term>Butorphanol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04436224
org study id: nfyyicu002
nct id: NCT04436224
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression
      and gastrointestinal motility. The study will further explore the continuous pumping-dose of
      hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma
      concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU
      non-mechanical ventilation patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: successful analgesic proportion
time frame: From date of using the intervention drugs until the date of leaving from icu, up to 28 days
description: Proportion of patients in each group who reached the target analgesia score range
measure: Score
time frame: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
description: analgesia score, such as CPOT or NRS
measure: dose of analgesics
time frame: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
description: total dose of analgesics during the study
measure: Adverse event
time frame: From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days
description: Adverse event during the study, including hypotension.et
measure: ICU stay
time frame: from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.
description: duration of stay in ICU
arm group label: hydromorphone
arm group type: Experimental
description: NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h
arm group label: fentanyl
arm group type: Active Comparator
description: NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h
arm group label: Butorphanol
arm group type: Active Comparator
description: NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h
intervention type: Drug
intervention name: Hydromorphone
description: Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
arm group label: hydromorphone
intervention type: Drug
intervention name: Fentanyl
description: Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
arm group label: fentanyl
intervention type: Drug
intervention name: Butorphanol
description: Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)
arm group label: Butorphanol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hongbin Hu, doctor
phone: +8613922483752
email: hobewoos@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Zhenhua Zen
investigator title: Associate Professor
mesh term: Agnosia
mesh term: Fentanyl
mesh term: Hydromorphone
mesh term: Butorphanol