<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/NCT04423224</url>
  </required_header>
  <id_info>
    <org_study_id>AttikonHSV</org_study_id>
    <nct_id>NCT04423224</nct_id>
  </id_info>
  <brief_title>Non-invasive Stroke Volume-based ﬂuid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia</brief_title>
  <acronym>AttikonHSV</acronym>
  <official_title>Non-invasive Stroke Volume-based ﬂuid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon 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>
      The study is going to be a single-centre prospective randomized trial. Patients will be&#xD;
      randomly allocated to either control group (anesthetist-directed fluid therapy) or goal&#xD;
      directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV)&#xD;
      algorithm with the use of Nexfin monitor. Primary outcome measures were the time to hospital&#xD;
      discharge since surgery and the occurence of complications developed during the postoperative&#xD;
      period. Secondary outcomes included the incidence of intraoperative hypotensive episodes&#xD;
      (with MAP&lt;65mmHg) in both groups and the requirement of vasoactive drugs to support blood&#xD;
      pressure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is going to be a single-centre prospective randomized trial in elderly patients&#xD;
      undergoing hip fracture surgery under spinal anesthesia.&#xD;
&#xD;
      Patients will be randomly allocated to either control group (anesthetist-directed fluid&#xD;
      therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke&#xD;
      volume (SV) algorithm with the use of Nexfin monitor.&#xD;
&#xD;
      In patients of the control group management of the hemodynamic status will be performed in&#xD;
      the discretion of the attending anesthesiologist, with the aim of keeping mean arterial&#xD;
      pressure (MAP) &gt; 65mmHg. The type and amount of delivered fluids, and vasoactive or inotropic&#xD;
      drugs will be recorded.&#xD;
&#xD;
      In Goal Directed Fluid Therapy group, fluid management will be guided by the Nexfin monitor,&#xD;
      based on stroke volume of the patient under continuous tracking. Baseline SV will be measured&#xD;
      after the patients will be turned to left/right position (at which they are going to stay&#xD;
      throughout the whole procedure) and before the implementation of regional anesthesia. Fluid&#xD;
      challenges of 250 ml will be repeated until the SV fails to increase by 10%. At this point,&#xD;
      preload is considered optimized and SV optimum iss defined. SV trigger is defined as SV opt -&#xD;
      10%. After obtaining these values, the anesthetic and surgical interventions could proceed.&#xD;
      During surgery, N/S 250ml boluses will be administered when SV is below SV trigger. Inotropic&#xD;
      drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if CO is below 3.5 L/min&#xD;
      and vasopressors (phenylephrine bolus doses of 50-100mcg) if SV and CO are within the target&#xD;
      range but MAP is below 65mmHg.&#xD;
&#xD;
      Primary outcome measures were the time to hospital discharge since surgery and the occurence&#xD;
      of complications developed during the postoperative period. Secondary outcomes included the&#xD;
      incidence of intraoperative hypotensive episodes (with MAP&lt;65mmHg) in both groups and the&#xD;
      requirement of vasoactive drugs to support blood pressure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</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>Control group Management of the hemodynamic status in the control group versus a goal directed group based on stroke volume variation protocol (with Nexfin monitor) in patients undergoing hip fracture fixation under spinal anesthesia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>days of hospitalization after surgery</measure>
    <time_frame>30 days</time_frame>
    <description>days of hospitalization after the operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>30 days</time_frame>
    <description>incidence of complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hypotension</measure>
    <time_frame>during surgery</time_frame>
    <description>incidence of hypotensive episodes (MAP &lt; 65mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of vasoactive agents</measure>
    <time_frame>during surgery</time_frame>
    <description>use of vasoactive agents (phenylephrine, dopamine) exact dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Fluid Management</condition>
  <condition>Haemodynamic Instability</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group Management of the hemodynamic status in the control group will be performed in the discretion of the attending anesthesiologist, with the aim of keeping mean arterial pressure (MAP) &gt; 65mmHg. The type and amount of delivered fluids, and vasoactive or inotropic drugs will be recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GDFM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Goal-directed fluid management group (GDFM). . Baseline SV will be measured after the patients will be turned to left/right position &amp; before implementation of regional anesthesia. Fluid challenges of 250 ml will be repeated until SV fails to increase by 10%. At this point, preload is considered optimized and SV optimum is defined. SV trigger is defined as SV opt - 10%. N/S 250ml boluses will be administered when SV is below SV trigger. Inotropic drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if CO is below 3.5 L/min and vasopressors (phenylephrine bolus doses of 50-100mcg) if SV and CO are within the target range but MAP is below 65mmHg. Patients will be reassessed during the intraoperative period every 10 minutes . Except from the fluid boluses, all patients will be administered Ringer's lactate solution at an infusion rate of 2ml/kg/h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GDFM</intervention_name>
    <description>Stroke volume variation fluid management</description>
    <arm_group_label>GDFM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>USUAL CARE - CONTROL</intervention_name>
    <description>Usual care fluid management</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for hip fracture repair&#xD;
&#xD;
          -  over 60 years of age&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status II, III, IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal or inability to consent,&#xD;
&#xD;
          -  a plan for general anesthesia&#xD;
&#xD;
          -  expected unreliable measurements of nexfin monitor (e.g. peripheral vascular disease,&#xD;
             finger edema).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>CHRYSANTHI BATISTAKI</last_name>
    <phone>00302105832371</phone>
    <email>chrysabatistaki@yahoo.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>2nd Department of Anaesthesiology, Attikon Hospital, 1 Rimini str.</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHRYSANTHI BATISTAKI, MD, PhD</last_name>
      <phone>+302105832371</phone>
      <email>chrysabatistaki@yahoo.gr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chrysanthi Batistaki, MD, PhD</last_name>
      <phone>0030 210 5832371</phone>
      <email>chrysabatistaki@yahoo.gr</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Chrysanthi Batistaki</investigator_full_name>
    <investigator_title>Associate Professor of Anaesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Fractures</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/NCT04423224
org study id: AttikonHSV
nct id: NCT04423224
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is going to be a single-centre prospective randomized trial. Patients will be
      randomly allocated to either control group (anesthetist-directed fluid therapy) or goal
      directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV)
      algorithm with the use of Nexfin monitor. Primary outcome measures were the time to hospital
      discharge since surgery and the occurence of complications developed during the postoperative
      period. Secondary outcomes included the incidence of intraoperative hypotensive episodes
      (with MAP<65mmHg) in both groups and the requirement of vasoactive drugs to support blood
      pressure
The study is going to be a single-centre prospective randomized trial in elderly patients
      undergoing hip fracture surgery under spinal anesthesia.

      Patients will be randomly allocated to either control group (anesthetist-directed fluid
      therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke
      volume (SV) algorithm with the use of Nexfin monitor.

      In patients of the control group management of the hemodynamic status will be performed in
      the discretion of the attending anesthesiologist, with the aim of keeping mean arterial
      pressure (MAP) > 65mmHg. The type and amount of delivered fluids, and vasoactive or inotropic
      drugs will be recorded.

      In Goal Directed Fluid Therapy group, fluid management will be guided by the Nexfin monitor,
      based on stroke volume of the patient under continuous tracking. Baseline SV will be measured
      after the patients will be turned to left/right position (at which they are going to stay
      throughout the whole procedure) and before the implementation of regional anesthesia. Fluid
      challenges of 250 ml will be repeated until the SV fails to increase by 10%. At this point,
      preload is considered optimized and SV optimum iss defined. SV trigger is defined as SV opt -
      10%. After obtaining these values, the anesthetic and surgical interventions could proceed.
      During surgery, N/S 250ml boluses will be administered when SV is below SV trigger. Inotropic
      drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if CO is below 3.5 L/min
      and vasopressors (phenylephrine bolus doses of 50-100mcg) if SV and CO are within the target
      range but MAP is below 65mmHg.

      Primary outcome measures were the time to hospital discharge since surgery and the occurence
      of complications developed during the postoperative period. Secondary outcomes included the
      incidence of intraoperative hypotensive episodes (with MAP<65mmHg) in both groups and the
      requirement of vasoactive drugs to support blood pressure
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Control group Management of the hemodynamic status in the control group versus a goal directed group based on stroke volume variation protocol (with Nexfin monitor) in patients undergoing hip fracture fixation under spinal anesthesia
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: days of hospitalization after surgery
time frame: 30 days
description: days of hospitalization after the operation
measure: complications
time frame: 30 days
description: incidence of complications
measure: hypotension
time frame: during surgery
description: incidence of hypotensive episodes (MAP < 65mmHg)
measure: use of vasoactive agents
time frame: during surgery
description: use of vasoactive agents (phenylephrine, dopamine) exact dose
arm group label: Control group
arm group type: Active Comparator
description: Control group Management of the hemodynamic status in the control group will be performed in the discretion of the attending anesthesiologist, with the aim of keeping mean arterial pressure (MAP) > 65mmHg. The type and amount of delivered fluids, and vasoactive or inotropic drugs will be recorded.
arm group label: GDFM
arm group type: Active Comparator
description: Goal-directed fluid management group (GDFM). . Baseline SV will be measured after the patients will be turned to left/right position & before implementation of regional anesthesia. Fluid challenges of 250 ml will be repeated until SV fails to increase by 10%. At this point, preload is considered optimized and SV optimum is defined. SV trigger is defined as SV opt - 10%. N/S 250ml boluses will be administered when SV is below SV trigger. Inotropic drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if CO is below 3.5 L/min and vasopressors (phenylephrine bolus doses of 50-100mcg) if SV and CO are within the target range but MAP is below 65mmHg. Patients will be reassessed during the intraoperative period every 10 minutes . Except from the fluid boluses, all patients will be administered Ringer's lactate solution at an infusion rate of 2ml/kg/h.
intervention type: Other
intervention name: GDFM
description: Stroke volume variation fluid management
arm group label: GDFM
intervention type: Other
intervention name: USUAL CARE - CONTROL
description: Usual care fluid management
arm group label: Control group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: CHRYSANTHI BATISTAKI
phone: 00302105832371
email: chrysabatistaki@yahoo.gr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Chrysanthi Batistaki
investigator title: Associate Professor of Anaesthesiology
mesh term: Hip Fractures
sharing ipd: Undecided