<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/NCT03784521</url>
  </required_header>
  <id_info>
    <org_study_id>116064</org_study_id>
    <nct_id>NCT03784521</nct_id>
  </id_info>
  <brief_title>Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery</brief_title>
  <official_title>Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol 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>
      The aim of this study is to demonstrated efficacy of in-line filtration to reduce systemic&#xD;
      inflammatory response syndrome (SIRS) ,specific organ dysfunction and complications in adult&#xD;
      cardiac surgery. 486 patients undergoing cardiac surgery for acquired heart disease are 1:1&#xD;
      randomized into in-line filtration (study group) and non-filtration (control group). The&#xD;
      incidence of SIRS, complications, daily SOFA (sequential organ failure assessment) score are&#xD;
      compared between groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok,&#xD;
      Thailand. The protocol has been approved by institutional ethical committee (ref. ID&#xD;
      11-60-64) with informed consent required for all patients.&#xD;
&#xD;
      The incidences of SIRS between the control and the filter group in pediatrics population from&#xD;
      previous study were 35% and 25.2% respectively (risk difference -11.3%, 95% CI -21.8 to&#xD;
      -0.5%). The author estimated the sample size of 486 randomized patients to give 80% power at&#xD;
      the 10% significant level (alpha 0.1, beta 0.8).&#xD;
&#xD;
      Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart&#xD;
      disease (including isolated coronary artery bypass grafting (CABG), isolated valve surgery,&#xD;
      combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into&#xD;
      in-line filtration (study group) and non-filtration (control group).&#xD;
&#xD;
      For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are&#xD;
      used for all intravenous access during operation and postoperative period in intensive care&#xD;
      unit (ICU).&#xD;
&#xD;
      For patients randomized to control group, All intravenous access is managed routinely&#xD;
      according to local standard care without filtration during operation and postoperative period&#xD;
      in ICU.&#xD;
&#xD;
      Primary endpoint of this study is the incidence of SIRS after cardiac surgery. SIRS is&#xD;
      diagnosed when patients have two or more of these criteria: 1.Heart rate &gt;90/min,&#xD;
      2.Temperature &gt;38 °C or &lt;36 °C, 3.Respiratory rate &gt;20/min or Paco2 &lt;32 mm Hg (4.3 kPa), and&#xD;
      4.White blood cell count &gt;12000/mm3 or &lt;4000/mm3 or &gt;10% immature band.&#xD;
&#xD;
      Secondary endpoints are complications as defined by Society of Thoracic Surgeons (STS) Adult&#xD;
      Cardiac Surgical Database, daily SOFA score and organ dysfunction as defined by The Third&#xD;
      International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).&#xD;
&#xD;
      Continuous data were reported as mean (standard deviation, SD) or median (interquartile&#xD;
      range, IQR) and compared by independent sample t-test or the Mann-Whitney U test. Categorical&#xD;
      variables were presented as frequency (%) and analyzed by chi-squared or Fisher's exact test.&#xD;
      Statistical significance was defined as a P-value &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">March 17, 2023</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>Prevention</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of SIRS after cardiac surgery</measure>
    <time_frame>SIRS is evaluated every 24 hours from immediate post-op to 96 hours postoperatively</time_frame>
    <description>SIRS is diagnosed when patients have two or more of these criteria: 1.Heart rate &gt;90/min, 2.Temperature &gt;38 °C or &lt;36 °C, 3.Respiratory rate &gt;20/min or Paco2 &lt;32 mm Hg (4.3 kPa), and 4.White blood cell count &gt;12000/mm3 or &lt;4000/mm3 or &gt;10% immature band.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily SOFA score</measure>
    <time_frame>SOFA score is evaluated every 24 hours from immediate post-op to 96 hours postoperatively</time_frame>
    <description>Daily SOFA score and organ dysfunction are as defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ has a possible dysfunction score of 0 to 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Operative mortality</measure>
    <time_frame>up to 1 month postoperatively</time_frame>
    <description>Operative mortality includes both (1) all deaths occurring during the hospitalization in which the operation was performed, even if after 30 days; and (2) those deaths occurring after discharge from the hospital, but within 30 days of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Permanent Stroke</measure>
    <time_frame>up to 1 month postoperatively</time_frame>
    <description>Postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Renal Failure</measure>
    <time_frame>up to 1 month postoperatively</time_frame>
    <description>Acute or worsening renal failure resulting in one or more of the following:&#xD;
Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level.&#xD;
A new requirement for dialysis postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Prolonged Ventilation &gt; 24 hours</measure>
    <time_frame>up to 1 month postoperatively</time_frame>
    <description>Prolonged post-operative pulmonary ventilation &gt; 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Deep sternal wound infection</measure>
    <time_frame>up to 1 month postoperatively</time_frame>
    <description>Deep sternal wound infection or mediastinitis (according to CDC definition) diagnosed within 30 days of the operation or any time during the hospitalization for the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Reoperation for any reason</measure>
    <time_frame>up to 1 month postoperatively</time_frame>
    <description>Reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Major Morbidity or Operative Mortality</measure>
    <time_frame>up to 1 month postoperatively</time_frame>
    <description>A composite endpoint defined as any of the outcomes listed above, including; Operative mortality, Permanent Stroke, Renal Failure, Prolonged Ventilation &gt; 24 hours, Deep sternal wound infection, Reoperation for any reason.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">486</enrollment>
  <condition>SIRS</condition>
  <arm_group>
    <arm_group_label>In-line filtration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used for all intravenous access during operation and postoperative period in intensive care unit (ICU).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients randomized to control group, All intravenous access is managed routinely according to local standard care without filtration during operation and postoperative period in ICU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>In-line filtration</intervention_name>
    <description>In-line filtration is used during anesthesia and intensive care unit in study group to purify fluids administrations.</description>
    <arm_group_label>In-line filtration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Patients are treated with standard intravenous solutions and vascular access management</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18 years or older undergoing elective adult cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Patient who does not want to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Narongrit Kantathut, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ramathibodi hospital, Mahidol University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Narongrit Kantathut, MD</last_name>
    <phone>(66)-2201-1000</phone>
    <phone_ext>1319</phone_ext>
    <email>narongrit.kan@mahidol.ac.th</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ramathibodi Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Narongrit Kantathut, MD</last_name>
      <phone>(66)-2201-1000</phone>
      <phone_ext>1319</phone_ext>
      <email>narongrit.kan@mahidol.ac.th</email>
    </contact>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Sasse M, Dziuba F, Jack T, Koditz H, Kaussen T, Bertram H, Beerbaum P, Boehne M. In-line Filtration Decreases Systemic Inflammatory Response Syndrome, Renal and Hematologic Dysfunction in Pediatric Cardiac Intensive Care Patients. Pediatr Cardiol. 2015 Aug;36(6):1270-8. doi: 10.1007/s00246-015-1157-x. Epub 2015 Apr 7.</citation>
    <PMID>25845941</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 19, 2023</last_update_submitted>
  <last_update_submitted_qc>March 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SIRS</keyword>
  <keyword>In-line filtration</keyword>
  <keyword>Cardiac surgery</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/NCT03784521
org study id: 116064
nct id: NCT03784521
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to demonstrated efficacy of in-line filtration to reduce systemic
      inflammatory response syndrome (SIRS) ,specific organ dysfunction and complications in adult
      cardiac surgery. 486 patients undergoing cardiac surgery for acquired heart disease are 1:1
      randomized into in-line filtration (study group) and non-filtration (control group). The
      incidence of SIRS, complications, daily SOFA (sequential organ failure assessment) score are
      compared between groups.
This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok,
      Thailand. The protocol has been approved by institutional ethical committee (ref. ID
      11-60-64) with informed consent required for all patients.

      The incidences of SIRS between the control and the filter group in pediatrics population from
      previous study were 35% and 25.2% respectively (risk difference -11.3%, 95% CI -21.8 to
      -0.5%). The author estimated the sample size of 486 randomized patients to give 80% power at
      the 10% significant level (alpha 0.1, beta 0.8).

      Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart
      disease (including isolated coronary artery bypass grafting (CABG), isolated valve surgery,
      combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into
      in-line filtration (study group) and non-filtration (control group).

      For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are
      used for all intravenous access during operation and postoperative period in intensive care
      unit (ICU).

      For patients randomized to control group, All intravenous access is managed routinely
      according to local standard care without filtration during operation and postoperative period
      in ICU.

      Primary endpoint of this study is the incidence of SIRS after cardiac surgery. SIRS is
      diagnosed when patients have two or more of these criteria: 1.Heart rate >90/min,
      2.Temperature >38 °C or <36 °C, 3.Respiratory rate >20/min or Paco2 <32 mm Hg (4.3 kPa), and
      4.White blood cell count >12000/mm3 or <4000/mm3 or >10% immature band.

      Secondary endpoints are complications as defined by Society of Thoracic Surgeons (STS) Adult
      Cardiac Surgical Database, daily SOFA score and organ dysfunction as defined by The Third
      International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

      Continuous data were reported as mean (standard deviation, SD) or median (interquartile
      range, IQR) and compared by independent sample t-test or the Mann-Whitney U test. Categorical
      variables were presented as frequency (%) and analyzed by chi-squared or Fisher's exact test.
      Statistical significance was defined as a P-value < 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Care Provider, Investigator)
measure: Incidence of SIRS after cardiac surgery
time frame: SIRS is evaluated every 24 hours from immediate post-op to 96 hours postoperatively
description: SIRS is diagnosed when patients have two or more of these criteria: 1.Heart rate >90/min, 2.Temperature >38 °C or <36 °C, 3.Respiratory rate >20/min or Paco2 <32 mm Hg (4.3 kPa), and 4.White blood cell count >12000/mm3 or <4000/mm3 or >10% immature band.
measure: Daily SOFA score
time frame: SOFA score is evaluated every 24 hours from immediate post-op to 96 hours postoperatively
description: Daily SOFA score and organ dysfunction are as defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ has a possible dysfunction score of 0 to 4.
measure: Incidence of Operative mortality
time frame: up to 1 month postoperatively
description: Operative mortality includes both (1) all deaths occurring during the hospitalization in which the operation was performed, even if after 30 days; and (2) those deaths occurring after discharge from the hospital, but within 30 days of the procedure.
measure: Incidence of Permanent Stroke
time frame: up to 1 month postoperatively
description: Postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.
measure: Incidence of Renal Failure
time frame: up to 1 month postoperatively
description: Acute or worsening renal failure resulting in one or more of the following:
Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level.
A new requirement for dialysis postoperatively.
measure: Incidence of Prolonged Ventilation > 24 hours
time frame: up to 1 month postoperatively
description: Prolonged post-operative pulmonary ventilation > 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation.
measure: Incidence of Deep sternal wound infection
time frame: up to 1 month postoperatively
description: Deep sternal wound infection or mediastinitis (according to CDC definition) diagnosed within 30 days of the operation or any time during the hospitalization for the surgery.
measure: Incidence of Reoperation for any reason
time frame: up to 1 month postoperatively
description: Reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason
measure: Incidence of Major Morbidity or Operative Mortality
time frame: up to 1 month postoperatively
description: A composite endpoint defined as any of the outcomes listed above, including; Operative mortality, Permanent Stroke, Renal Failure, Prolonged Ventilation > 24 hours, Deep sternal wound infection, Reoperation for any reason.
arm group label: In-line filtration
arm group type: Experimental
description: For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used for all intravenous access during operation and postoperative period in intensive care unit (ICU).
arm group label: Control
arm group type: Active Comparator
description: For patients randomized to control group, All intravenous access is managed routinely according to local standard care without filtration during operation and postoperative period in ICU.
intervention type: Device
intervention name: In-line filtration
description: In-line filtration is used during anesthesia and intensive care unit in study group to purify fluids administrations.
arm group label: In-line filtration
intervention type: Device
intervention name: Standard care
description: Patients are treated with standard intravenous solutions and vascular access management
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Narongrit Kantathut, MD
role: Principal Investigator
affiliation: Ramathibodi hospital, Mahidol University
last name: Narongrit Kantathut, MD
phone: (66)-2201-1000
phone ext: 1319
email: narongrit.kan@mahidol.ac.th
facility: 
status: Recruiting
contact: 
country: Thailand
citation: Sasse M, Dziuba F, Jack T, Koditz H, Kaussen T, Bertram H, Beerbaum P, Boehne M. In-line Filtration Decreases Systemic Inflammatory Response Syndrome, Renal and Hematologic Dysfunction in Pediatric Cardiac Intensive Care Patients. Pediatr Cardiol. 2015 Aug;36(6):1270-8. doi: 10.1007/s00246-015-1157-x. Epub 2015 Apr 7.
PMID: 25845941
responsible party type: Sponsor
sharing ipd: No