<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/NCT04474600</url>
  </required_header>
  <id_info>
    <org_study_id>Anesthetics_Nx_AKI</org_study_id>
    <nct_id>NCT04474600</nct_id>
  </id_info>
  <brief_title>Anesthesia and Acute Kidney Injury After Nephrectomy</brief_title>
  <official_title>The Influence of Type of Anesthesia on Postoperative Renal Function After Nephrectomy: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      This study investigates the influence of type of anesthesia on postoperative renal&#xD;
      dysfunction in patients undergoing nephrectomy. The participants will be allocated to either&#xD;
      the group receiving the total intravenous anesthesia (TIVA) using propofol or the group&#xD;
      receiving the inhaled anesthetics using desflurane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nephrectomy is considered as a standard therapy for renal cell carcinoma, but it can cause&#xD;
      postoperative renal dysfunction, such as acute kidney injury and chronic kidney disease.&#xD;
      Therefore, it is imperative to identify modifiable risk factors for postoperative acute&#xD;
      kidney injury after nephrectomy in advance. According to a recent retrospective study, total&#xD;
      intravenous anesthesia using propofol is significantly associated with lower incidence of&#xD;
      acute kidney injury after nephrectomy, compared to the inhalation anesthesia. However, there&#xD;
      is no prospective study which investigates the influence of type of anesthesia on&#xD;
      postoperative renal function after nephrectomy. Therefore, in the present study, we aimed to&#xD;
      investigate the influence of type of anesthesia on acute kidney injury after nephrectomy by&#xD;
      performing randomized controlled study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of acute kidney injury</measure>
    <time_frame>during the postoperative seven days</time_frame>
    <description>acute kidney injury (diagnosed by AKIN criteria)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum creatinine</measure>
    <time_frame>postoperative day 1, 3, 14</time_frame>
    <description>postoperative result of serum creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated glomerular filtration rate</measure>
    <time_frame>postoperative day 1, 3, 14</time_frame>
    <description>postoperative result of estimated glomerular filtration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biomarker of renal injury</measure>
    <time_frame>postoperative day 1, 3, 14</time_frame>
    <description>postoperative result of biomarker of renal injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the incidence of postoperative complications</measure>
    <time_frame>during the postoperative two weeks</time_frame>
    <description>urine leakage, prolonged ileus, wound infection, retroperitoneal abscess, pneumonia, reoperation, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>during the postoperative two weeks</time_frame>
    <description>length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of intensive care unit stay</measure>
    <time_frame>during the postoperative two weeks</time_frame>
    <description>length of intensive care unit stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">324</enrollment>
  <condition>Nephrectomy</condition>
  <arm_group>
    <arm_group_label>TIVA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the total intravenous anesthesia using propofol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inhalation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving inhalation anesthesia using desflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>The induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol. In both groups, remifentanil is continuously infused throughout the surgery.</description>
    <arm_group_label>TIVA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>The induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane. In both groups, remifentanil is continuously infused throughout the surgery.</description>
    <arm_group_label>Inhalation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults patients scheduled for elective open nephrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with acute kidney injury preoperatively&#xD;
&#xD;
          -  Patients who have chronic kidney disease over stage 5 (estimated glomerular filtration&#xD;
             rate [eGFR] &lt;15 ml/kg/1.73m2) or have regular hemodialysis preoperatively&#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>Hyun-Kyu Yoon, MD</last_name>
    <phone>+821095188501</phone>
    <phone_ext>+82220720065</phone_ext>
    <email>hyunkyu18@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hyun-Kyu Yoon</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyun-Kyu Yoon, MD</last_name>
      <phone>02-2072-0065</phone>
      <email>Hyunkyu18@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hyun-Kyu Yoon</investigator_full_name>
    <investigator_title>clinical assistant professor</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Propofol</keyword>
  <keyword>Inhaled anesthetics</keyword>
  <keyword>Acute kidney injury</keyword>
  <keyword>Nephrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04474600
org study id: Anesthetics_Nx_AKI
nct id: NCT04474600
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the influence of type of anesthesia on postoperative renal
      dysfunction in patients undergoing nephrectomy. The participants will be allocated to either
      the group receiving the total intravenous anesthesia (TIVA) using propofol or the group
      receiving the inhaled anesthetics using desflurane.
Nephrectomy is considered as a standard therapy for renal cell carcinoma, but it can cause
      postoperative renal dysfunction, such as acute kidney injury and chronic kidney disease.
      Therefore, it is imperative to identify modifiable risk factors for postoperative acute
      kidney injury after nephrectomy in advance. According to a recent retrospective study, total
      intravenous anesthesia using propofol is significantly associated with lower incidence of
      acute kidney injury after nephrectomy, compared to the inhalation anesthesia. However, there
      is no prospective study which investigates the influence of type of anesthesia on
      postoperative renal function after nephrectomy. Therefore, in the present study, we aimed to
      investigate the influence of type of anesthesia on acute kidney injury after nephrectomy by
      performing randomized controlled study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: the incidence of acute kidney injury
time frame: during the postoperative seven days
description: acute kidney injury (diagnosed by AKIN criteria)
measure: serum creatinine
time frame: postoperative day 1, 3, 14
description: postoperative result of serum creatinine
measure: estimated glomerular filtration rate
time frame: postoperative day 1, 3, 14
description: postoperative result of estimated glomerular filtration rate
measure: biomarker of renal injury
time frame: postoperative day 1, 3, 14
description: postoperative result of biomarker of renal injury
measure: the incidence of postoperative complications
time frame: during the postoperative two weeks
description: urine leakage, prolonged ileus, wound infection, retroperitoneal abscess, pneumonia, reoperation, etc.
measure: Length of hospital stay
time frame: during the postoperative two weeks
description: length of hospital stay
measure: Length of intensive care unit stay
time frame: during the postoperative two weeks
description: length of intensive care unit stay
arm group label: TIVA group
arm group type: Experimental
description: Patients receiving the total intravenous anesthesia using propofol
arm group label: Inhalation group
arm group type: Active Comparator
description: Patients receiving inhalation anesthesia using desflurane
intervention type: Drug
intervention name: Propofol
description: The induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol. In both groups, remifentanil is continuously infused throughout the surgery.
arm group label: TIVA group
intervention type: Drug
intervention name: Desflurane
description: The induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane. In both groups, remifentanil is continuously infused throughout the surgery.
arm group label: Inhalation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hyun-Kyu Yoon, MD
phone: +821095188501
phone ext: +82220720065
email: hyunkyu18@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hyun-Kyu Yoon
investigator title: clinical assistant professor
mesh term: Acute Kidney Injury
mesh term: Propofol
mesh term: Desflurane
sharing ipd: No