<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/NCT04482946</url>
  </required_header>
  <id_info>
    <org_study_id>Dyn Test-and-Index</org_study_id>
    <nct_id>NCT04482946</nct_id>
  </id_info>
  <brief_title>Dynamic Tests and Parameters to Predict Fluid Responsiveness After OPCAB</brief_title>
  <official_title>Dynamic Tests and Parameters to Predict Fluid Responsiveness After Off-pump Coronary Artery Bypass Grafting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northern State Medical University</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>
      Objective: To assess the predictive value of dynamic tests and parameters for evaluation of&#xD;
      fluid responsiveness after off-pump coronary artery bypass grafting (OPCAB).&#xD;
&#xD;
      After arrival to ICU, all patients received positive end-expiratory pressure test&#xD;
      (PEEP-test), mini-fluid challenge test (mFCT) and standard fluid challenge test (sFCT) to&#xD;
      assess fluid responsiveness. In addition, investigators measured pulse pressure variation&#xD;
      using two monitoring systems (PPVPiCCO and PPVNK), stroke volume variation (SVV), heart-lung&#xD;
      interaction index (HLI) and plethysmogram variability index (PVI) before and after sFCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients were intubated using the standard induction technique with sodium thiopental (4&#xD;
      mg/kg), fentanyl (2.5-3.0 mcg/kg) and pipecuronium bromide (0.1 mg/kg). Anaesthesia was&#xD;
      maintained using sevoflurane (0.5-3.0 vol.% at the end of expiration) and fentanyl (2.0-4.0&#xD;
      mcg/kg/hr). Depth of anaesthesia was adjusted to maintain bispectral index (BIS) values&#xD;
      between 40-60 (LifeScope, Nihon Kohden, Japan).&#xD;
&#xD;
      In all cases, preoxygenation with 80% O2 was provided during 3-5 minutes before anesthesia.&#xD;
      After tracheal intubation, patients were ventilated using a protective volume-controlled mode&#xD;
      (Dräger Primus, Germany) with tidal volume of 6-8 mL/kg of predicted body weight, flow of 1&#xD;
      L/min and positive end-expiratory pressure (PEEP) of 5 cm H2O. The value of FiO2 was set to&#xD;
      at least 50% or higher to achieve intraoperative SpO2 above 95%. The respiratory rate was&#xD;
      adjusted to maintain end-tidal CO2 values within 30-35 mm Hg.&#xD;
&#xD;
      All the patients were operated by the same team of surgeons using Acrobat SUV OM-9000S&#xD;
      (Guidant, Santa Clara, USA) device for stabilization of the heart during revascularization.&#xD;
&#xD;
      After surgery, all patients were transferred to the postoperative cardiac ICU and sedated&#xD;
      during 60 min with continuous infusion of propofol (2-4 mcg/kg/hr) to maintain BIS values&#xD;
      within 60-70. Respiratory support in ICU was continued by a G5 ventilator (Hamilton Medical,&#xD;
      Switzerland) using pressure controlled ventilation mode with parameters same as for&#xD;
      intraoperative period.&#xD;
&#xD;
      Investigators provided invasive hemodynamic monitoring (PiCCO2, Pulsion Medical Systems,&#xD;
      Germany; Nihon Kohden, MU-671RK, Japan) to all patients. After the initial stabilization of&#xD;
      patient, investigators performed three dynamic tests in a consequent order. The positive&#xD;
      end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to&#xD;
      20 cm H2O during 120 seconds. The PEEP-test was interrupted if mean arterial pressure (MAP)&#xD;
      decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5&#xD;
      L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5&#xD;
      mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid&#xD;
      challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10&#xD;
      minutes. During PEEP-test and mFCT, investigators performed continuous monitoring of MAP,&#xD;
      SVV, PPV and PCCI (PiCCO2). Investigators also measured SVV, PPVPiCCO, PVVNK (Nihon Kohden),&#xD;
      HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) before and after sFCT. In addition,&#xD;
      investigators assessed cardiac index (CI), extravascular lung water index (EVLWI) and global&#xD;
      end-diastolic volume index (GEDVI) using transpulmonary thermodilution (PiCCO2). During the&#xD;
      study, investigators measured arterial blood gases and lactate concentration. The patients&#xD;
      who demonstrated an increase in CI ≥ 15 % after sFCT were defined as fluid responders.10, 11&#xD;
      After the initial measurements, sedation was stopped, and the weaning from respiratory&#xD;
      support was initiated. The weaning protocol included gradual decrease of inspiratory pressure&#xD;
      and mandatory respiratory rate followed by spontaneous breathing trial after achieving&#xD;
      pressure support of 8 cm H2O. After passing the 30-min spontaneous breathing trial, all the&#xD;
      patients were extubated and received oxygen inhalation via facial mask.&#xD;
&#xD;
      In addition to hemodynamic and respiratory parameters, recorded the preoperative EuroScore&#xD;
      II, duration of postoperative mechanical ventilation, length of ICU stay and fluid balance&#xD;
      after OPCAB and on postoperative Day 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Predictive value of dynamic tests</measure>
    <time_frame>immediately postoperatively</time_frame>
    <description>To assess if changes in mean arterial pressure, pulse pressure variation and stroke volume variation by more than 10% during the PEEP-test and mini fluid challenge test can predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictive value of dynamic parameters</measure>
    <time_frame>immediately postoperatively</time_frame>
    <description>To assess the ability of the decrement of Pulse pressure variation (measured by Nikhon), Heart-lung interaction index (HLI) and Pulse variability index (PVI) by more than 3% to predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Assessment of fluid responsiveness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Assessment of fluid responsiveness</intervention_name>
    <description>The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.</description>
    <arm_group_label>Assessment of fluid responsiveness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        elective OPCAB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        morbid obesity with body mass index &gt; 40 kg/m2 constant atrial fibrillation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mikhail Y Kirov, PhD</last_name>
    <email>mikhail_kirov@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eugenia V Fot</last_name>
    <phone>89212950685</phone>
    <email>ev_fot@mail.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>City Hospital # 1 n.a. E.E. Volosevich</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mikhail Kirov, PhD</last_name>
      <email>mikhail_kirov@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northern State Medical University</investigator_affiliation>
    <investigator_full_name>Mikhail Y. Kirov</investigator_full_name>
    <investigator_title>Head of the anesthesiology and intensive care department</investigator_title>
  </responsible_party>
  <keyword>fluid responsiveness</keyword>
  <keyword>dynamic tests</keyword>
  <keyword>dynamic parameters</keyword>
  <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/NCT04482946
org study id: Dyn Test-and-Index
nct id: NCT04482946
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To assess the predictive value of dynamic tests and parameters for evaluation of
      fluid responsiveness after off-pump coronary artery bypass grafting (OPCAB).

      After arrival to ICU, all patients received positive end-expiratory pressure test
      (PEEP-test), mini-fluid challenge test (mFCT) and standard fluid challenge test (sFCT) to
      assess fluid responsiveness. In addition, investigators measured pulse pressure variation
      using two monitoring systems (PPVPiCCO and PPVNK), stroke volume variation (SVV), heart-lung
      interaction index (HLI) and plethysmogram variability index (PVI) before and after sFCT.
All patients were intubated using the standard induction technique with sodium thiopental (4
      mg/kg), fentanyl (2.5-3.0 mcg/kg) and pipecuronium bromide (0.1 mg/kg). Anaesthesia was
      maintained using sevoflurane (0.5-3.0 vol.% at the end of expiration) and fentanyl (2.0-4.0
      mcg/kg/hr). Depth of anaesthesia was adjusted to maintain bispectral index (BIS) values
      between 40-60 (LifeScope, Nihon Kohden, Japan).

      In all cases, preoxygenation with 80% O2 was provided during 3-5 minutes before anesthesia.
      After tracheal intubation, patients were ventilated using a protective volume-controlled mode
      (Dräger Primus, Germany) with tidal volume of 6-8 mL/kg of predicted body weight, flow of 1
      L/min and positive end-expiratory pressure (PEEP) of 5 cm H2O. The value of FiO2 was set to
      at least 50% or higher to achieve intraoperative SpO2 above 95%. The respiratory rate was
      adjusted to maintain end-tidal CO2 values within 30-35 mm Hg.

      All the patients were operated by the same team of surgeons using Acrobat SUV OM-9000S
      (Guidant, Santa Clara, USA) device for stabilization of the heart during revascularization.

      After surgery, all patients were transferred to the postoperative cardiac ICU and sedated
      during 60 min with continuous infusion of propofol (2-4 mcg/kg/hr) to maintain BIS values
      within 60-70. Respiratory support in ICU was continued by a G5 ventilator (Hamilton Medical,
      Switzerland) using pressure controlled ventilation mode with parameters same as for
      intraoperative period.

      Investigators provided invasive hemodynamic monitoring (PiCCO2, Pulsion Medical Systems,
      Germany; Nihon Kohden, MU-671RK, Japan) to all patients. After the initial stabilization of
      patient, investigators performed three dynamic tests in a consequent order. The positive
      end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to
      20 cm H2O during 120 seconds. The PEEP-test was interrupted if mean arterial pressure (MAP)
      decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5
      L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5
      mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid
      challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10
      minutes. During PEEP-test and mFCT, investigators performed continuous monitoring of MAP,
      SVV, PPV and PCCI (PiCCO2). Investigators also measured SVV, PPVPiCCO, PVVNK (Nihon Kohden),
      HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) before and after sFCT. In addition,
      investigators assessed cardiac index (CI), extravascular lung water index (EVLWI) and global
      end-diastolic volume index (GEDVI) using transpulmonary thermodilution (PiCCO2). During the
      study, investigators measured arterial blood gases and lactate concentration. The patients
      who demonstrated an increase in CI ≥ 15 % after sFCT were defined as fluid responders.10, 11
      After the initial measurements, sedation was stopped, and the weaning from respiratory
      support was initiated. The weaning protocol included gradual decrease of inspiratory pressure
      and mandatory respiratory rate followed by spontaneous breathing trial after achieving
      pressure support of 8 cm H2O. After passing the 30-min spontaneous breathing trial, all the
      patients were extubated and received oxygen inhalation via facial mask.

      In addition to hemodynamic and respiratory parameters, recorded the preoperative EuroScore
      II, duration of postoperative mechanical ventilation, length of ICU stay and fluid balance
      after OPCAB and on postoperative Day 1.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Predictive value of dynamic tests
time frame: immediately postoperatively
description: To assess if changes in mean arterial pressure, pulse pressure variation and stroke volume variation by more than 10% during the PEEP-test and mini fluid challenge test can predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).
measure: Predictive value of dynamic parameters
time frame: immediately postoperatively
description: To assess the ability of the decrement of Pulse pressure variation (measured by Nikhon), Heart-lung interaction index (HLI) and Pulse variability index (PVI) by more than 3% to predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).
arm group label: Assessment of fluid responsiveness
arm group type: Experimental
description: The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.
intervention type: Diagnostic Test
intervention name: Assessment of fluid responsiveness
description: The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.
arm group label: Assessment of fluid responsiveness
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mikhail Y Kirov, PhD
email: mikhail_kirov@hotmail.com
last name: Eugenia V Fot
phone: 89212950685
email: ev_fot@mail.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Northern State Medical University
investigator full name: Mikhail Y. Kirov
investigator title: Head of the anesthesiology and intensive care department
sharing ipd: No