xml: <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/NCT05971121</url>
    </required_header>
    <id_info>
      <org_study_id>NFEC-2022-525</org_study_id>
      <nct_id>NCT05971121</nct_id>
    </id_info>
    <brief_title>Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study</brief_title>
    <official_title>Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort 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>
        This study was a single-center, prospective, 2-year observational cohort study. The study&#xD;
        subjects were ICU patients requiring vasopressor drugs and requiring sedation. According to&#xD;
        the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge&#xD;
        according to the condition of the subjects), they were divided into groups: ciprofol group&#xD;
        and propofol group. A total of 456 subjects were planned to be enrolled, including 304&#xD;
        subjects in the cyclopofol group and 152 subjects in the propofol group. The data of this&#xD;
        study were obtained by extracting the routine clinical diagnosis and treatment records of the&#xD;
        enrolled subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The proportion of patients meeting the RASS sedation</measure>
      <time_frame>within 24 hours</time_frame>
      <description>Professionally trained researchers perform RASS scores on patients at specific time points</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dosage of propofol or ciprofol during sedation (total dose/time of use)</measure>
      <time_frame>up to 24 hours</time_frame>
      <description>Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dosage of norepinephrine during sedation (total dose/time of use)</measure>
      <time_frame>up to 24 hours</time_frame>
      <description>Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of mechanical ventilation</measure>
      <time_frame>From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days</time_frame>
      <description>Responsible researchers obtain information by viewing electronic medical records</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>up to 3 days</time_frame>
      <description>The occurrence of adverse events during the hospital period will be recorded in the medical record by the clinician or nurse, and the researcher will obtain the occurrence of adverse events (event type, time, treatment, results, etc.) through the medical record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of ICU stay</measure>
      <time_frame>up to 28 days</time_frame>
      <description>Researchers obtain it through the hospital electronic system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The mortality rate</measure>
      <time_frame>up to 28 days</time_frame>
      <description>Researchers obtain it through the hospital electronic system.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">456</enrollment>
    <condition>Ciprofol</condition>
    <condition>Propofol</condition>
    <condition>Sedation</condition>
    <condition>Low Blood Pressure</condition>
    <condition>Norepinephrine</condition>
    <arm_group>
      <arm_group_label>ciprofol group</arm_group_label>
      <description>Hypotensive ICU patient sedated with ciprofol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>propofol group</arm_group_label>
      <description>Hypotensive ICU patient sedated with propofol</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ciprofol</intervention_name>
      <description>Ciprofol were used for sedation in ICU hypotensive patients</description>
      <arm_group_label>ciprofol group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          In the Department of Critical Care Medicine, Nanfang Hospital, Southern Medical University,&#xD;
          patients needing vasopressor drugs to maintain blood pressure while requiring sedation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18;&#xD;
  &#xD;
            -  It needs to be treated with vasopressors to maintain mean arterial pressure ≥65 mmHg;&#xD;
  &#xD;
            -  Sedative medication required for comfort, safety, and to facilitate life support&#xD;
               measures;&#xD;
  &#xD;
            -  Obtain the informed consent of the human subjects or their legal representatives.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant patient;&#xD;
  &#xD;
            -  Patients with proven acute severe intracranial or spinal neurological disease due to&#xD;
               vascular, intracranial dilatation, or injury;&#xD;
  &#xD;
            -  History of allergy to cyclopofol, propofol, eggs, or soy products;&#xD;
  &#xD;
            -  History of long-term use of benzodiazepines or opioids;&#xD;
  &#xD;
            -  Sedative drugs other than propofol or cyclopofol were used at enrollment, or propofol&#xD;
               and cyclopofol were used alternately within 24 hours;&#xD;
  &#xD;
            -  The researchers judged that they are not suitable to participate in this study.&#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>Zengzhu He, master</last_name>
      <phone>+8615766358044</phone>
      <email>hzengzhu@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hongbin Hu, doctor</last_name>
      <phone>+8613922483752</phone>
      <email>hobewoos@163.com</email>
    </overall_contact_backup>
    <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>July 2023</verification_date>
    <study_first_submitted>May 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypotension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971121
  org study id: NFEC-2022-525
  nct id: NCT05971121
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study was a single-center, prospective, 2-year observational cohort study. The study
        subjects were ICU patients requiring vasopressor drugs and requiring sedation. According to
        the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge
        according to the condition of the subjects), they were divided into groups: ciprofol group
        and propofol group. A total of 456 subjects were planned to be enrolled, including 304
        subjects in the cyclopofol group and 152 subjects in the propofol group. The data of this
        study were obtained by extracting the routine clinical diagnosis and treatment records of the
        enrolled subjects.
  observational model: Case-Control
  time perspective: Prospective
  measure: The proportion of patients meeting the RASS sedation
  time frame: within 24 hours
  description: Professionally trained researchers perform RASS scores on patients at specific time points
  measure: Dosage of propofol or ciprofol during sedation (total dose/time of use)
  time frame: up to 24 hours
  description: Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
  measure: Dosage of norepinephrine during sedation (total dose/time of use)
  time frame: up to 24 hours
  description: Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
  measure: Duration of mechanical ventilation
  time frame: From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days
  description: Responsible researchers obtain information by viewing electronic medical records
  measure: Incidence of adverse events
  time frame: up to 3 days
  description: The occurrence of adverse events during the hospital period will be recorded in the medical record by the clinician or nurse, and the researcher will obtain the occurrence of adverse events (event type, time, treatment, results, etc.) through the medical record
  measure: length of ICU stay
  time frame: up to 28 days
  description: Researchers obtain it through the hospital electronic system
  measure: The mortality rate
  time frame: up to 28 days
  description: Researchers obtain it through the hospital electronic system.
  arm group label: ciprofol group
  description: Hypotensive ICU patient sedated with ciprofol
  arm group label: propofol group
  description: Hypotensive ICU patient sedated with propofol
  intervention type: Drug
  intervention name: ciprofol
  description: Ciprofol were used for sedation in ICU hypotensive patients
  arm group label: ciprofol group
  blood
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zengzhu He, master
  phone: +8615766358044
  email: hzengzhu@163.com
  last name: Hongbin Hu, doctor
  phone: +8613922483752
  email: hobewoos@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Hypotension
  sharing ipd: Undecided