<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/NCT03795805</url>
  </required_header>
  <id_info>
    <org_study_id>R-2018-3401-053</org_study_id>
    <nct_id>NCT03795805</nct_id>
  </id_info>
  <brief_title>After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet</brief_title>
  <official_title>After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Mexicano del Seguro Social</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Mexicano del Seguro Social</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>
      This study analize the incidence of acute renal failure after performing total knee&#xD;
      arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in&#xD;
      a randomized clinical trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study analize the incidence of acute renal failure after performing total knee&#xD;
      arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb&#xD;
      cuff (half of patients for each group) in a randomized clinical trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2018</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2018</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>
    <intervention_model_description>Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Creatinin before surgery</measure>
    <time_frame>Creatinin before surgery</time_frame>
    <description>Blood Creatinin meassure in mg/dl before surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinin after surgery 1</measure>
    <time_frame>Creatinin after surgery 1 at 24 hours</time_frame>
    <description>Blood Creatinin meassure in mg/dl at 24 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinin after surgery 2</measure>
    <time_frame>Creatinin after surgery 2 at 48 hours</time_frame>
    <description>Blood Creatinin meassure in mg/dl at 48 hours</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Tourniquets</condition>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>TKA and Tourniquet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intraarticular lidocain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total knee arthroplasty with Intaarticular lidocain</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>total knee arthroplasty</intervention_name>
    <description>Total knee arhroplasty</description>
    <arm_group_label>Intraarticular lidocain</arm_group_label>
    <arm_group_label>TKA and Tourniquet</arm_group_label>
    <other_name>TKA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tourniquet limb cuff</intervention_name>
    <description>Tourniquet limb cuff and regular anesthesia</description>
    <arm_group_label>TKA and Tourniquet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intaarticular lidocain</intervention_name>
    <description>20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)</description>
    <arm_group_label>Intraarticular lidocain</arm_group_label>
    <other_name>lidocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients knee arthrosis&#xD;
&#xD;
          -  Required a surgical treatment with Total Knee Arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not accept to be in the study&#xD;
&#xD;
          -  Not signed consent form&#xD;
&#xD;
          -  Not having blood sample for creatinin meassure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avelino Colin Vázquez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IMSS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMAE Dr. Victorio de La Fuente Narvaez</name>
      <address>
        <city>Ciudad de México</city>
        <zip>07020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Mexicano del Seguro Social</investigator_affiliation>
    <investigator_full_name>JUAN LOPEZ VALENCIA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will share only de demographic data and trial results</ipd_description>
  </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/NCT03795805
org study id: R-2018-3401-053
nct id: NCT03795805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study analize the incidence of acute renal failure after performing total knee
      arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in
      a randomized clinical trial
This study analize the incidence of acute renal failure after performing total knee
      arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb
      cuff (half of patients for each group) in a randomized clinical trial
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Clinical Trial
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Creatinin before surgery
time frame: Creatinin before surgery
description: Blood Creatinin meassure in mg/dl before surgery
measure: Creatinin after surgery 1
time frame: Creatinin after surgery 1 at 24 hours
description: Blood Creatinin meassure in mg/dl at 24 hours
measure: Creatinin after surgery 2
time frame: Creatinin after surgery 2 at 48 hours
description: Blood Creatinin meassure in mg/dl at 48 hours
arm group label: TKA and Tourniquet
arm group type: Other
description: Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg
arm group label: Intraarticular lidocain
arm group type: Experimental
description: Total knee arthroplasty with Intaarticular lidocain
intervention type: Procedure
intervention name: total knee arthroplasty
description: Total knee arhroplasty
arm group label: Intraarticular lidocain
arm group label: TKA and Tourniquet
other name: TKA
intervention type: Procedure
intervention name: Tourniquet limb cuff
description: Tourniquet limb cuff and regular anesthesia
arm group label: TKA and Tourniquet
intervention type: Drug
intervention name: Intaarticular lidocain
description: 20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)
arm group label: Intraarticular lidocain
other name: lidocaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Avelino Colin Vázquez, MD
role: Principal Investigator
affiliation: IMSS
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Mexicano del Seguro Social
investigator full name: JUAN LOPEZ VALENCIA
investigator title: Principal Investigator
mesh term: Acute Kidney Injury
mesh term: Renal Insufficiency
mesh term: Lidocaine
sharing ipd: No
ipd description: We will share only de demographic data and trial results