<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/NCT03765645</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS Liver Transplant 001</org_study_id>
    <nct_id>NCT03765645</nct_id>
  </id_info>
  <brief_title>Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors</brief_title>
  <official_title>Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors: A Randomized Controlled Trial</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>
      Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious&#xD;
      use of antibiotics is therefore of extreme importance not just in preventing antibiotic&#xD;
      resistance but also it decreases cost of the treatment and prevent side-effects of the&#xD;
      antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in&#xD;
      patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual&#xD;
      institutional protocol. There have been studies, comparing short course vs long dose of&#xD;
      antibiotics in hepatectomy patients, concluding equivalent efficacy in preventing infective&#xD;
      complications. The investigators aim at proving that 3 doses of antibiotics are equally&#xD;
      effective in preventing infective complications, when compared to 9 doses of antibiotics, in&#xD;
      patients undergoing donor hepatectomy. So, a randomized trial is required to study the&#xD;
      antibiotic duration in patient undergoing donor hepatectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious&#xD;
      use of antibiotics is therefore of extreme importance not just in preventing antibiotic&#xD;
      resistance but also it decreases cost of the treatment and prevent side-effects of the&#xD;
      antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in&#xD;
      patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual&#xD;
      institutional protocol. So, a randomized trial is required to study the antibiotic duration&#xD;
      in patient undergoing donor hepatectomy.&#xD;
&#xD;
      The investigators aim to prove that, in preventing infective complications, 3 doses of&#xD;
      antibiotics are equally effective as compared to 9 doses of antibiotics in patients of donor&#xD;
      hepatectomy.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      The present study will be an equivalence randomized control trial where data will be&#xD;
      collected from patients who are undergoing donor hepatectomy. Donor evaluation will be done&#xD;
      according to institutional protocol. Donor evaluation will be done step wise as tabulated&#xD;
      below.&#xD;
&#xD;
      Surgical technique After opening the abdomen through a J-shaped incision, cholecystectomy&#xD;
      will be performed and intraoperative cholangiogram will be carried out through the cystic&#xD;
      duct stump. The ipsilateral lobe will be mobilized and the hepatic vein will be looped. Hilar&#xD;
      dissection will be performed and the ipsilateral portal vein and hepatic artery are defined.&#xD;
      The transection plane will be determined by the line of demarcation obtained by temporary&#xD;
      clamping of the ipsilateral portal vein and hepatic artery. Parenchymal transection will be&#xD;
      performed without inflow occlusion by a Cavitron Ultrasonic Surgical Aspirator (CUSA_;&#xD;
      Valleylab, Boulder, CO, USA). The last one-third of the transaction will be performed with a&#xD;
      hanging maneuver. After completion of the transaction, the bile duct will be looped along&#xD;
      with the sheath and a repeat cholangiogram will be performed by placing radio opaque markers&#xD;
      at the proposed bile duct transection site. The bile duct will be divided between the&#xD;
      markers. Intravenous heparin will be given (50 IU/kg); after waiting for 3 min, the hepatic&#xD;
      artery, portal vein and hepatic vein will be divided between clamps and the graft will be&#xD;
      taken out.&#xD;
&#xD;
      Assumptions:&#xD;
&#xD;
        -  Prevalence of infective complications with 3 doses of antibiotic: 9%&#xD;
&#xD;
        -  Prevalence of infective complications with 9 doses of antibiotic: 7% The alpha error,&#xD;
           the power of the study and the equivalence margin will be taken as 5%, 80% and 15%&#xD;
           respectively. For this investigators will need to enroll a total of 108 patients,&#xD;
           equally divided into 2 groups.&#xD;
&#xD;
      Group A shall include 54 consecutive patients who are undergoing donor hepatectomy. These&#xD;
      patients will be followed up closely in the post-operative period and would be serially&#xD;
      sampled at pre-defined intervals. Patients will be assessed for infective complications.&#xD;
      Antibiotics will be continued beyond 3 doses, if any sign of infection is present (Fever/ TLC&#xD;
      more than 11,000/ Wound infection/others).&#xD;
&#xD;
      Group B shall include 54 patients, who will receive antibiotics for 3 days. These patients&#xD;
      will also be followed up closely in the post-operative period and would be serially sampled&#xD;
      at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics&#xD;
      will be continued beyond 3 days, if any sign of infection is present (Fever/ TLC more than&#xD;
      11,000/ Wound infection/others).&#xD;
&#xD;
      Infective complication rates / total duration of antibiotics/ cost of antibiotics and&#xD;
      morbidity will be compared between the 2 cohorts.&#xD;
&#xD;
      EXPECTED OUTCOME: To establish that 3 doses of antibiotics are equally effective in&#xD;
      preventing infective complications, as compared to 9 doses of antibiotics, in patients&#xD;
      undergoing donor hepatectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2018</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of infective complications</measure>
    <time_frame>1 year</time_frame>
    <description>The number of infective complications (CDC guidelines) in post operative period will be compared among patients receiving 3 doses vs patients receiving 9 doses of antibiotics.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Antibiotic Prophylaxis</condition>
  <condition>Postoperative Infection</condition>
  <arm_group>
    <arm_group_label>3 doses on intra venous antibiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 3 doses of intra venous antibiotics. (1 dose preoperative, 1 intra operative and 1 post-operative)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>9 doses of intra venous antibiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 9 doses of intra venous antibiotics. (1 dose preoperative, rest 8 doses at equal intervals)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piperacillin + Tazobactam</intervention_name>
    <description>Antibiotic used will be Piperacillin + Tazobactam Dose: 4.5 g, thrice a day at regular intervals Route: Intra-venous</description>
    <arm_group_label>3 doses on intra venous antibiotics</arm_group_label>
    <arm_group_label>9 doses of intra venous antibiotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All patient undergoing donor hepatectomy consent for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients refusing consent for inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Viniyendra Pamecha</last_name>
    <role>Principal Investigator</role>
    <affiliation>ILBS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ILBS</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver Transplant</keyword>
  <keyword>Donor Hepatectomy</keyword>
  <keyword>Antibiotic prophylaxis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tazobactam</mesh_term>
    <mesh_term>Piperacillin</mesh_term>
    <mesh_term>Piperacillin, Tazobactam Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03765645
org study id: ILBS Liver Transplant 001
nct id: NCT03765645
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious
      use of antibiotics is therefore of extreme importance not just in preventing antibiotic
      resistance but also it decreases cost of the treatment and prevent side-effects of the
      antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in
      patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual
      institutional protocol. There have been studies, comparing short course vs long dose of
      antibiotics in hepatectomy patients, concluding equivalent efficacy in preventing infective
      complications. The investigators aim at proving that 3 doses of antibiotics are equally
      effective in preventing infective complications, when compared to 9 doses of antibiotics, in
      patients undergoing donor hepatectomy. So, a randomized trial is required to study the
      antibiotic duration in patient undergoing donor hepatectomy.
Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious
      use of antibiotics is therefore of extreme importance not just in preventing antibiotic
      resistance but also it decreases cost of the treatment and prevent side-effects of the
      antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in
      patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual
      institutional protocol. So, a randomized trial is required to study the antibiotic duration
      in patient undergoing donor hepatectomy.

      The investigators aim to prove that, in preventing infective complications, 3 doses of
      antibiotics are equally effective as compared to 9 doses of antibiotics in patients of donor
      hepatectomy.

      Methodology:

      The present study will be an equivalence randomized control trial where data will be
      collected from patients who are undergoing donor hepatectomy. Donor evaluation will be done
      according to institutional protocol. Donor evaluation will be done step wise as tabulated
      below.

      Surgical technique After opening the abdomen through a J-shaped incision, cholecystectomy
      will be performed and intraoperative cholangiogram will be carried out through the cystic
      duct stump. The ipsilateral lobe will be mobilized and the hepatic vein will be looped. Hilar
      dissection will be performed and the ipsilateral portal vein and hepatic artery are defined.
      The transection plane will be determined by the line of demarcation obtained by temporary
      clamping of the ipsilateral portal vein and hepatic artery. Parenchymal transection will be
      performed without inflow occlusion by a Cavitron Ultrasonic Surgical Aspirator (CUSA_;
      Valleylab, Boulder, CO, USA). The last one-third of the transaction will be performed with a
      hanging maneuver. After completion of the transaction, the bile duct will be looped along
      with the sheath and a repeat cholangiogram will be performed by placing radio opaque markers
      at the proposed bile duct transection site. The bile duct will be divided between the
      markers. Intravenous heparin will be given (50 IU/kg); after waiting for 3 min, the hepatic
      artery, portal vein and hepatic vein will be divided between clamps and the graft will be
      taken out.

      Assumptions:

        -  Prevalence of infective complications with 3 doses of antibiotic: 9%

        -  Prevalence of infective complications with 9 doses of antibiotic: 7% The alpha error,
           the power of the study and the equivalence margin will be taken as 5%, 80% and 15%
           respectively. For this investigators will need to enroll a total of 108 patients,
           equally divided into 2 groups.

      Group A shall include 54 consecutive patients who are undergoing donor hepatectomy. These
      patients will be followed up closely in the post-operative period and would be serially
      sampled at pre-defined intervals. Patients will be assessed for infective complications.
      Antibiotics will be continued beyond 3 doses, if any sign of infection is present (Fever/ TLC
      more than 11,000/ Wound infection/others).

      Group B shall include 54 patients, who will receive antibiotics for 3 days. These patients
      will also be followed up closely in the post-operative period and would be serially sampled
      at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics
      will be continued beyond 3 days, if any sign of infection is present (Fever/ TLC more than
      11,000/ Wound infection/others).

      Infective complication rates / total duration of antibiotics/ cost of antibiotics and
      morbidity will be compared between the 2 cohorts.

      EXPECTED OUTCOME: To establish that 3 doses of antibiotics are equally effective in
      preventing infective complications, as compared to 9 doses of antibiotics, in patients
      undergoing donor hepatectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of infective complications
time frame: 1 year
description: The number of infective complications (CDC guidelines) in post operative period will be compared among patients receiving 3 doses vs patients receiving 9 doses of antibiotics.
arm group label: 3 doses on intra venous antibiotics
arm group type: Active Comparator
description: Patients will receive 3 doses of intra venous antibiotics. (1 dose preoperative, 1 intra operative and 1 post-operative)
arm group label: 9 doses of intra venous antibiotics
arm group type: Active Comparator
description: Patients will receive 9 doses of intra venous antibiotics. (1 dose preoperative, rest 8 doses at equal intervals)
intervention type: Drug
intervention name: Piperacillin + Tazobactam
description: Antibiotic used will be Piperacillin + Tazobactam Dose: 4.5 g, thrice a day at regular intervals Route: Intra-venous
arm group label: 3 doses on intra venous antibiotics
arm group label: 9 doses of intra venous antibiotics
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Dr. Viniyendra Pamecha
role: Principal Investigator
affiliation: ILBS
facility: 
country: India
responsible party type: Sponsor
mesh term: Tazobactam
mesh term: Piperacillin
mesh term: Piperacillin, Tazobactam Drug Combination
sharing ipd: Undecided