<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/NCT03265470</url>
  </required_header>
  <id_info>
    <org_study_id>MD ∕ 15.08.78</org_study_id>
    <nct_id>NCT03265470</nct_id>
  </id_info>
  <brief_title>Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy</brief_title>
  <official_title>The Potential Renal Protective Effect of Intravenous Dexmedetomidine for Patients During Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute kidney injury and chronic kidney disease usually associated with radical cystectomy&#xD;
      operation which is the treatment of choice for invasive urinary bladders tumor.&#xD;
      Peri-operative acute kidney injury (AKI) is common but poorly recognized and managed which is&#xD;
      associated with increase surgical morbidity and mortality and hospital cost .Prospective&#xD;
      human studies establishing a renal protective effect of dexmedetomidine are still&#xD;
      questionable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to test the hypothesis that intra-operative intravenous&#xD;
      dexmedetomidine infusion could improve early renal function after open radical cystectomy.&#xD;
&#xD;
      This randomized comparative study will be carried out on 100 patients of either sex, ASA I&#xD;
      and II with baseline serum creatinine below 1.4 mg/dl who will be submitted for radical&#xD;
      cystectomy. The patients will be randomly allocated into two groups according to the drug&#xD;
      infused intra-operatively; dexmedetomidine group and fentanyl group. Dexmedetomidine group:&#xD;
      will receive loading dose (0.8μg/kg) over 20 minutes, followed by intravenous infusion&#xD;
      (0.4μg/kg/h) and fentanyl group: will receive loading dose (1μg/kg), followed by intravenous&#xD;
      infusion (1μg/kg/h) during intra-operative period till end of procedure. Assessment of renal&#xD;
      function through evaluation of pre-operative estimated glomerular filtration rate (eGFR)&#xD;
      using Modification of Diet in Renal Disease (MDRD) formula based on baseline serum&#xD;
      creatinine, serum cystatin C level at 24 hours post-operative, daily post-operative serum&#xD;
      creatinine for one week post-operative and post-operative eGFR using MDRD formula.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2015</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum cystatin C level</measure>
    <time_frame>For 24 hours after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>For 7 days after surgery</time_frame>
    <description>Daily morning over the first post-operative week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative eGFR</measure>
    <time_frame>For 7 days after surgery</time_frame>
    <description>daily within the first week post-operative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral oxygen saturation (SpO2)</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-tidal carbon dioxide tension</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume of crystalloid solutions used</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume of colloid solutions used</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume of packed red blood cells transfused</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative occurrence of hypotension</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative occurrence of bradycardia</measure>
    <time_frame>For 8 hours after induction of general anesthesia</time_frame>
    <description>recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Radical Cystectomy</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received intravenous infusion of dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received intravenous infusion of fentanyl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Patients will receive Loading dose of dexmedetomidine (0.8μg/kg) over 20 minutes, followed by intravenous infusion (0.4μg/kg/h) during intra-operative period till end of procedure.</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.</description>
    <arm_group_label>Fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status I or II.&#xD;
&#xD;
          -  Patients scheduled for elective radical cystectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serum creatinine level equal or greater than 1.4 mg/dl.&#xD;
&#xD;
          -  Allergy to alpha-2 adrenergic agonist&#xD;
&#xD;
          -  Allergy to any anesthetic drugs&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Uncontrolled diabetes.&#xD;
&#xD;
          -  Heart block greater than first degree.&#xD;
&#xD;
          -  History of alcohol abuse.&#xD;
&#xD;
          -  History of drug abuse.&#xD;
&#xD;
          -  Clinically significant neurologic disease.&#xD;
&#xD;
          -  Clinically significant cardiovascular disease.&#xD;
&#xD;
          -  Clinically significant respiratory disease.&#xD;
&#xD;
          -  Clinically significant hepatic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Golinar E Hammouda, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura university</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 5, 2020</last_update_submitted>
  <last_update_submitted_qc>September 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Dexmedetomidine</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/NCT03265470
org study id: MD ∕ 15.08.78
nct id: NCT03265470
lead sponsor: 
has dmc: Yes
Acute kidney injury and chronic kidney disease usually associated with radical cystectomy
      operation which is the treatment of choice for invasive urinary bladders tumor.
      Peri-operative acute kidney injury (AKI) is common but poorly recognized and managed which is
      associated with increase surgical morbidity and mortality and hospital cost .Prospective
      human studies establishing a renal protective effect of dexmedetomidine are still
      questionable.
The aim of this study is to test the hypothesis that intra-operative intravenous
      dexmedetomidine infusion could improve early renal function after open radical cystectomy.

      This randomized comparative study will be carried out on 100 patients of either sex, ASA I
      and II with baseline serum creatinine below 1.4 mg/dl who will be submitted for radical
      cystectomy. The patients will be randomly allocated into two groups according to the drug
      infused intra-operatively; dexmedetomidine group and fentanyl group. Dexmedetomidine group:
      will receive loading dose (0.8μg/kg) over 20 minutes, followed by intravenous infusion
      (0.4μg/kg/h) and fentanyl group: will receive loading dose (1μg/kg), followed by intravenous
      infusion (1μg/kg/h) during intra-operative period till end of procedure. Assessment of renal
      function through evaluation of pre-operative estimated glomerular filtration rate (eGFR)
      using Modification of Diet in Renal Disease (MDRD) formula based on baseline serum
      creatinine, serum cystatin C level at 24 hours post-operative, daily post-operative serum
      creatinine for one week post-operative and post-operative eGFR using MDRD formula.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Serum cystatin C level
time frame: For 24 hours after surgery
measure: Serum creatinine
time frame: For 7 days after surgery
description: Daily morning over the first post-operative week
measure: Post-operative eGFR
time frame: For 7 days after surgery
description: daily within the first week post-operative
measure: Heart rate
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: Mean arterial blood pressure
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: Peripheral oxygen saturation (SpO2)
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: End-tidal carbon dioxide tension
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: Total volume of crystalloid solutions used
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: Total volume of colloid solutions used
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: Total volume of packed red blood cells transfused
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: Intraoperative occurrence of hypotension
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
measure: Intraoperative occurrence of bradycardia
time frame: For 8 hours after induction of general anesthesia
description: recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
arm group label: Dexmedetomidine
arm group type: Experimental
description: Patients received intravenous infusion of dexmedetomidine
arm group label: Fentanyl
arm group type: Active Comparator
description: Patients received intravenous infusion of fentanyl
intervention type: Drug
intervention name: Dexmedetomidine
description: Patients will receive Loading dose of dexmedetomidine (0.8μg/kg) over 20 minutes, followed by intravenous infusion (0.4μg/kg/h) during intra-operative period till end of procedure.
arm group label: Dexmedetomidine
intervention type: Drug
intervention name: Fentanyl
description: Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.
arm group label: Fentanyl
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Golinar E Hammouda, MD
role: Study Chair
affiliation: Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Fentanyl
mesh term: Dexmedetomidine
sharing ipd: Undecided