<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/NCT03260309</url>
  </required_header>
  <id_info>
    <org_study_id>VilniusU</org_study_id>
    <nct_id>NCT03260309</nct_id>
  </id_info>
  <brief_title>The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes</brief_title>
  <official_title>The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vilnius University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaunas University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vilnius University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Success of the hip arthroplasty depends on the measures that optimize perioperative&#xD;
      conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Success of the total hip arthroplasty depends on the measures that optimize perioperative&#xD;
      conditions. They increase the emotional stress of the staff and error probability. It is&#xD;
      planned to evaluate semi-closed loop infusion system, its adaption for infusion application's&#xD;
      influence to near and far treatment outcomes done by prospective randomized clinical trial.&#xD;
      This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed&#xD;
      loop system's influence on the doctor's emotional tension during the decision making.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The efficiency of semi-closed loop infusion system</measure>
    <time_frame>Before the surgery and 12 hrs postoperatively</time_frame>
    <description>Determine the ratio of doctor's approved and rejected computer suggestions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative blood loss</measure>
    <time_frame>Before (baseline) the surgery,during surgery and 24hrs postoperatively</time_frame>
    <description>Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coagulation activity</measure>
    <time_frame>Before (baseline) the surgery and 24hrs postoperatively</time_frame>
    <description>Coagulation activity is investigated thromboelastically</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infused fluid and red blood cell volume</measure>
    <time_frame>Before the surgery and 24hrs postoperatively</time_frame>
    <description>Repeated rehydration bolus (sol.Ringeri 2,5ml/kg), supportive fluid infusion (sol.NaCl 0,9% 1,5 ml/kg/hrs); evaluation of signs of anemia intolerance if Hb &lt; 110 g/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>Within 6 days postoperatively</time_frame>
    <description>Evaluation of wound tissue condition, measurement of drainage fluid volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage physical exercise sample</measure>
    <time_frame>Within 6 days postoperatively</time_frame>
    <description>Timed up and go test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemodynamic stability</measure>
    <time_frame>Before (baseline) the surgery and 12 hrs postoperatively</time_frame>
    <description>Invasive measurement of arterial blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Within 6 days postoperatively</time_frame>
    <description>Registration of all complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Hip Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>semi-closed system group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser&quot; and programmable syringe pump for adrenaline infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Routine infusion therapy tactic</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Semi-closed loop infusion system tactic.</intervention_name>
    <description>Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser&quot; and programmable syringe pump for adrenaline infusion.</description>
    <arm_group_label>semi-closed system group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Routine infusion therapy tactic</intervention_name>
    <description>Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal -&#xD;
             epidural anesthesia&#xD;
&#xD;
          -  Age &gt;50 and &lt;85 years&#xD;
&#xD;
          -  ASA (American Society of Anesthesiology Classification) II physical status&#xD;
&#xD;
          -  Start of operation no later than 09:00&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;50 and &gt;85 yers&#xD;
&#xD;
          -  BMI (Body Mass Index) &lt;20 and &gt;40 kg/m2&#xD;
&#xD;
          -  ASA I and ASA&gt;II physical status&#xD;
&#xD;
          -  History of a bleeding disorder&#xD;
&#xD;
          -  Anemia before surgery Hb&lt;110 g/l&#xD;
&#xD;
          -  Intravascular fluid infusion within 24 hours before study&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Previous open hip surgery&#xD;
&#xD;
          -  Psychiatric illness (intake of other psychiatric medication than selective serotonin&#xD;
             reuptake inhibitors)&#xD;
&#xD;
          -  Alcohol intake 5 U daily&#xD;
&#xD;
          -  Contraindication to spinal - epidural anesthesia&#xD;
&#xD;
          -  Surgery not by project surgeon&#xD;
&#xD;
          -  Start of operation later than 09:00&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Narcotic addiction&#xD;
&#xD;
          -  History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac&#xD;
             insufficiency&#xD;
&#xD;
          -  Participation in the other study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrijauskas Audrius, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vilnius University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>February 29, 2016</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vilnius University</investigator_affiliation>
    <investigator_full_name>Darius Cincikas</investigator_full_name>
    <investigator_title>Audrius Andrijauskas PhD , principal investigator, clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_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/NCT03260309
org study id: VilniusU
nct id: NCT03260309
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Success of the hip arthroplasty depends on the measures that optimize perioperative
      conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.
Success of the total hip arthroplasty depends on the measures that optimize perioperative
      conditions. They increase the emotional stress of the staff and error probability. It is
      planned to evaluate semi-closed loop infusion system, its adaption for infusion application's
      influence to near and far treatment outcomes done by prospective randomized clinical trial.
      This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed
      loop system's influence on the doctor's emotional tension during the decision making.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: The efficiency of semi-closed loop infusion system
time frame: Before the surgery and 12 hrs postoperatively
description: Determine the ratio of doctor's approved and rejected computer suggestions
measure: Perioperative blood loss
time frame: Before (baseline) the surgery,during surgery and 24hrs postoperatively
description: Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume
measure: Coagulation activity
time frame: Before (baseline) the surgery and 24hrs postoperatively
description: Coagulation activity is investigated thromboelastically
measure: Infused fluid and red blood cell volume
time frame: Before the surgery and 24hrs postoperatively
description: Repeated rehydration bolus (sol.Ringeri 2,5ml/kg), supportive fluid infusion (sol.NaCl 0,9% 1,5 ml/kg/hrs); evaluation of signs of anemia intolerance if Hb < 110 g/l
measure: Wound healing
time frame: Within 6 days postoperatively
description: Evaluation of wound tissue condition, measurement of drainage fluid volume
measure: Dosage physical exercise sample
time frame: Within 6 days postoperatively
description: Timed up and go test
measure: Haemodynamic stability
time frame: Before (baseline) the surgery and 12 hrs postoperatively
description: Invasive measurement of arterial blood pressure
measure: Complications
time frame: Within 6 days postoperatively
description: Registration of all complications
arm group label: semi-closed system group
arm group type: Experimental
description: Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.
arm group label: control group
arm group type: Experimental
description: Routine infusion therapy tactic
intervention type: Procedure
intervention name: Semi-closed loop infusion system tactic.
description: Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.
arm group label: semi-closed system group
intervention type: Procedure
intervention name: Routine infusion therapy tactic
description: Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.
arm group label: control group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andrijauskas Audrius, PhD
role: Principal Investigator
affiliation: Vilnius University
responsible party type: Principal Investigator
investigator affiliation: Vilnius University
investigator full name: Darius Cincikas
investigator title: Audrius Andrijauskas PhD , principal investigator, clinical professor
mesh term: Osteoarthritis, Hip
sharing ipd: Undecided