<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/NCT03837145</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-TRANSPLANT ANESTHESIA-01</org_study_id>
    <nct_id>NCT03837145</nct_id>
  </id_info>
  <brief_title>Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.</brief_title>
  <official_title>Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients-An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      All consenting, adult patients aged 18 years and above who will require elective ventilation&#xD;
      after liver transplant recipient surgery will be enrolled for the study. Patients in acute&#xD;
      liver failure, hepatic encephalopathy or patients with history of allergic reactions to&#xD;
      propofol will be excluded from the study. This is an observational study. As per institute&#xD;
      treatment protocol, propofol will be given post-operatively at a dose of 1 mg/kg/hr and than&#xD;
      titrated to maintain a Bi-Spectral Index (BIS) score of 60-80 till the patient is on&#xD;
      ventilator. There will be no deviation from our routine institutional protocol and no other&#xD;
      sedative drugs like opioids or benzodiazepines will be used and no interventions will be&#xD;
      done. Hemodynamics will be maintained targeting a mean arterial pressure (MAP) of at least 65&#xD;
      mm Hg. during the study period using appropriate measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 12, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Dosage of propofol in mg/kg/hr required for sedation (BIS:60-80) of postoperative electively ventilated living donor liver transplant recipients.</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Every 2 hrly , the continuous intravenous Propofol dose going on will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of propofol dose over the study period to maintain BIS between 60 -80</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Propofol doses will be recorded titrated to BIS of 60-80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the mean dose of propofol in mg/kg/hr with Arterial ammonia at baseline and to see the association between immediate post operative and Postoperative day1 ammonia with corresponding propofol dose.</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Arterial ammonia levels will be noted pre-operatively, immediate post-operative and after extubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of propofol dose with respective arterial lactate levels every 2 hours during the period of elective ventilation</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Lactate levels will be recorded every 2 hrs till the patient is on ventilator</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Liver Cirrhoses</condition>
  <arm_group>
    <arm_group_label>Liver transplant recipients</arm_group_label>
    <description>Adult patients requiring elective post-operative ventilation after a living donor liver transplant receiving intravenous propofol infusion for sedation titrated to Bi-Spectral Index (BIS) score of 60-80,as per our institutional protocol.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All consenting LDLT recipient adult patients ≥ 18 years of age who require postoperative&#xD;
        elective ventilation after recieving a living donor liver transplant.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Living donor liver transplant (LDLT) recipient adult patients ≥ 18 years of age requiring&#xD;
        postoperative elective ventilation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Propofol allergy&#xD;
&#xD;
          -  Acute liver failure (ALF).&#xD;
&#xD;
          -  Hepatic encephalopathy (HE)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>rishabh jaju, DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of liver and biliary sciences,New Delhi-110070</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rishabh jaju, DNB</last_name>
    <phone>7742454477</phone>
    <email>rishabh.cares@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kelika Prakash, DM</last_name>
    <phone>9540947117</phone>
    <email>kelika.prakash@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of liver and biliary sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>rishabh jaju, DNB</last_name>
      <phone>7742454477</phone>
      <email>rishabh.cares@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>kelika prakash, DM</last_name>
      <phone>9540947117</phone>
      <email>kelika.prakash@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Liver and Biliary Sciences, India</investigator_affiliation>
    <investigator_full_name>Rishabh Jaju</investigator_full_name>
    <investigator_title>senior resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_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/NCT03837145
org study id: ILBS-TRANSPLANT ANESTHESIA-01
nct id: NCT03837145
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
All consenting, adult patients aged 18 years and above who will require elective ventilation
      after liver transplant recipient surgery will be enrolled for the study. Patients in acute
      liver failure, hepatic encephalopathy or patients with history of allergic reactions to
      propofol will be excluded from the study. This is an observational study. As per institute
      treatment protocol, propofol will be given post-operatively at a dose of 1 mg/kg/hr and than
      titrated to maintain a Bi-Spectral Index (BIS) score of 60-80 till the patient is on
      ventilator. There will be no deviation from our routine institutional protocol and no other
      sedative drugs like opioids or benzodiazepines will be used and no interventions will be
      done. Hemodynamics will be maintained targeting a mean arterial pressure (MAP) of at least 65
      mm Hg. during the study period using appropriate measures.
observational model: Case-Only
time perspective: Prospective
measure: Dosage of propofol in mg/kg/hr required for sedation (BIS:60-80) of postoperative electively ventilated living donor liver transplant recipients.
time frame: up to 24 hours
description: Every 2 hrly , the continuous intravenous Propofol dose going on will be recorded.
measure: Changes of propofol dose over the study period to maintain BIS between 60 -80
time frame: up to 24 hours
description: Propofol doses will be recorded titrated to BIS of 60-80
measure: Correlation of the mean dose of propofol in mg/kg/hr with Arterial ammonia at baseline and to see the association between immediate post operative and Postoperative day1 ammonia with corresponding propofol dose.
time frame: up to 24 hours
description: Arterial ammonia levels will be noted pre-operatively, immediate post-operative and after extubation.
measure: Correlation of propofol dose with respective arterial lactate levels every 2 hours during the period of elective ventilation
time frame: up to 24 hours
description: Lactate levels will be recorded every 2 hrs till the patient is on ventilator
arm group label: Liver transplant recipients
description: Adult patients requiring elective post-operative ventilation after a living donor liver transplant receiving intravenous propofol infusion for sedation titrated to Bi-Spectral Index (BIS) score of 60-80,as per our institutional protocol.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: rishabh jaju, DNB
role: Principal Investigator
affiliation: Institute of liver and biliary sciences,New Delhi-110070
last name: Rishabh jaju, DNB
phone: 7742454477
email: rishabh.cares@gmail.com
last name: Kelika Prakash, DM
phone: 9540947117
email: kelika.prakash@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Institute of Liver and Biliary Sciences, India
investigator full name: Rishabh Jaju
investigator title: senior resident
mesh term: Liver Cirrhosis