<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/NCT01724463</url>
  </required_header>
  <id_info>
    <org_study_id>eASSIST-M</org_study_id>
    <nct_id>NCT01724463</nct_id>
  </id_info>
  <brief_title>Electronic Application of a Severe Sepsis Screening Tool and Management Bundle</brief_title>
  <acronym>eASSIST-M</acronym>
  <official_title>Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle Study to Improve Sepsis Related Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thousands of children die from Sepsis following routine infections. Many of these deaths can&#xD;
      be prevented with earlier recognition and focused management. No tools are currently&#xD;
      available to recognize the signs of early sepsis in children. The investigators have&#xD;
      developed a electronic health record-based tool that will recognize children with sepsis&#xD;
      early and trigger an alert to their hospital caregivers. The caregivers will be prompted to&#xD;
      launch a focused management bundle that can stabilize these children, prevent further&#xD;
      deterioration and reduce their chances of sepsis related complications and death. The&#xD;
      proposed study will test the validity and effectiveness of this electronic tool in reducing&#xD;
      sepsis mortality rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project: Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool&#xD;
      and Management Bundle (eASSIST-M) Study&#xD;
&#xD;
      Study Type: Prospective Cohort Outcomes Study&#xD;
&#xD;
      Background: Early recognition of severe sepsis is critical for the institution of goal-&#xD;
      directed therapy and for improving patient outcomes. Barriers to early recognition include&#xD;
      the lack of standardized tools to identify children with severe sepsis. The investigators&#xD;
      will study the potential impact of applying a novel Pediatric Severe Sepsis Screening Tool&#xD;
      (PSSST) integrated with the Electronic Health Record (EHR) to facilitate earlier detection&#xD;
      and effective management of severe sepsis.&#xD;
&#xD;
      Population: Patients between the ages 1 month and 18 years admitted to the hospital or&#xD;
      presenting to the Emergency Department (ED) with clinical signs of Systemic Inflammatory&#xD;
      Response Syndrome (SIRS).&#xD;
&#xD;
      Primary Hypothesis: Prospective application of a PSSST electronically integrated with the EHR&#xD;
      can accurately diagnose pediatric patients with early signs of severe sepsis.&#xD;
&#xD;
      Primary Outcome Measure: Proportion of correctly diagnosed patients with severe sepsis among&#xD;
      those presenting with SIRS will be assessed to prospectively validate the sensitivity,&#xD;
      specificity, positive and negative predictive values of the PSSST tool.&#xD;
&#xD;
      Secondary Hypothesis 1: Application of the PSSST will reduce lag-time for the administration&#xD;
      of a goal-directed sepsis therapy bundle by 50%.&#xD;
&#xD;
      Outcome Measure: Time delay from diagnostic identification to critical therapeutic&#xD;
      intervention. Sepsis Recognition Lag Time will be defined as the time elapsed from the first&#xD;
      electronic alert to the first therapeutic intervention. Therapeutic interventions will be&#xD;
      defined as Cardiopulmonary Resuscitation (CPR), fluid resuscitation, initiation of&#xD;
      cardiotonic agents, or request for transfer to the ICU. Since this is an intent-to-diagnose&#xD;
      study, outcomes defined above will be compared with those for the same period in the&#xD;
      preceding year.&#xD;
&#xD;
      Secondary Hypothesis 2: Application of a severe sepsis management bundle will reduce&#xD;
      mortality and morbidity.&#xD;
&#xD;
      Outcome Measure: Proportion of deaths in the study population due to severe sepsis. Morbidity&#xD;
      will be defined as the number of ventilator days, days on vasopressor or inotropic agents,&#xD;
      days of Extracorporeal Membrane Oxygenation (ECMO) support, need for tracheostomy, need for&#xD;
      Gastrostomy tube.&#xD;
&#xD;
      Proposed Study Design:&#xD;
&#xD;
      The investigators will conduct a prospective study where patients within the ED and inpatient&#xD;
      units are electronically screened using the PSSST during a 3-year study period. Patients will&#xD;
      be screened using a novel electronic tracking tool designed locally, using pre-defined severe&#xD;
      sepsis variables and validated on patients with severe sepsis. Patients screened as positive&#xD;
      for severe sepsis using the electronic tracking tool will be treated prospectively with a&#xD;
      standardized severe sepsis management bundle. Data will be collected prospectively on all&#xD;
      patients admitted to the ED and inpatient units. For the ED and each inpatient unit, the&#xD;
      outcomes defined above will be compared with those for the same period in the preceding year.&#xD;
&#xD;
      Covariates: Demographic, clinical characteristics and sepsis-specific factors that could&#xD;
      potentially influence the effect of the alerts on critical intervention.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      To assess the effectiveness of this tool, we will compare the proportions of the population&#xD;
      with each variable of interest between the intervention and prior periods.&#xD;
&#xD;
        1. To assess the efficacy of the PSSST, we will compare the changes over time in the&#xD;
           proportion of patients diagnosed severe sepsis adjusting for key covariates of interest.&#xD;
&#xD;
        2. To assess the effectiveness of the PSSST in reducing treatment delays, we will compare&#xD;
           changes in the Sepsis Recognition Lag Time between the intervention and control periods,&#xD;
           while adjusting for key covariates of interest.&#xD;
&#xD;
        3. To assess the efficacy of the PSSST in reducing mortality, we will compare the changes&#xD;
           in the age and risk adjusted mortality rates over time between the intervention and&#xD;
           control periods.&#xD;
&#xD;
      The investigators will use a robust variance estimate for all analyses to account for the&#xD;
      clustering of patients within units. We will also use propensity scores to control for&#xD;
      differences in patient characteristics and diagnostic categories.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of the Pediatric Severe Sepsis Screening Tool</measure>
    <time_frame>Average 60 days - Patients will be followed up until hospital discharge</time_frame>
    <description>Proportion of correctly diagnosed patients with severe sepsis among those presenting with SIRS will be assessed to prospectively validate the sensitivity, specificity, positive and negative predictive values of the PSSST tool.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time delay from diagnostic identification to critical therapeutic intervention in patients with Severe Sepsis.</measure>
    <time_frame>Average 60 days - Patients will be followed up until hospital discharge</time_frame>
    <description>Sepsis Recognition Lag Time will be defined as the time elapsed from the first electronic alert to the first therapeutic intervention. Therapeutic interventions will be defined as Cardiopulmonary Resuscitation (CPR), fluid resuscitation, initiation of cardiotonic agents, or request for transfer to the ICU. Since this is an intent-to-diagnose study, outcomes defined above will be compared with those for the same period in the preceding year.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Morbidity and Mortality Rates from Severe Sepsis</measure>
    <time_frame>Average 60 days - Patients will be followed up until hospital discharge</time_frame>
    <description>Morbidity will be defined as the number of ventilator days, days on vasopressor or inotropic agents, days of Extracorporeal Membrane Oxygenation (ECMO) support, need for tracheostomy, need for Gastrostomy tube. Mortality will be defined as the proportion of deaths in children with severe sepsis.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30000</enrollment>
  <condition>Systemic Inflammatory Response Syndrome (SIRS)</condition>
  <condition>Sepsis</condition>
  <condition>Severe Sepsis</condition>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Electronically Screened Sepsis Patients</arm_group_label>
    <description>Patients between the ages 1 month and 18 years admitted to the hospital or presenting to the Emergency Department (ED) with clinical signs of Systemic Inflammatory Response Syndrome (SIRS) electronically screened for severe sepsis. Patients screened as positive will receive an evidence based goal directed severe sepsis management bundle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Severe Sepsis Management Bundle</intervention_name>
    <description>Management Bundle includes:&#xD;
Securing Intravenous Access&#xD;
Obtaining Blood Culture&#xD;
Antibiotic Administration&#xD;
Goal Directed Fluid Bolus Therapy&#xD;
Oxygen Administration&#xD;
Measuring Serum Lactate Levels</description>
    <arm_group_label>Electronically Screened Sepsis Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients between the ages 1 month and 18 years admitted to the hospital or presenting to&#xD;
        the Emergency Department (ED) with clinical signs of Systemic Inflammatory Response&#xD;
        Syndrome (SIRS).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 1 month - 18 years&#xD;
&#xD;
          2. Clinical Suspicion of Infection&#xD;
&#xD;
          3. Patients in the Hospital or Emergency Department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Status Asthmaticus patients on active bronchodilator therapy&#xD;
&#xD;
          2. Patients receiving Anesthesia&#xD;
&#xD;
          3. Day Surgery Patients&#xD;
&#xD;
          4. Outpatient Clinic Patients&#xD;
&#xD;
          5. Congenital Heart Disease Patients&#xD;
&#xD;
          6. Myocarditis Neonates Patients older than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samir H Shah, MBBS MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee Health Sciences Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kanwaljeet S Anand, MBBS FCCM</last_name>
    <role>Study Director</role>
    <affiliation>University of Tennessee Health Sciences Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samir H Shah, MBBS, MBA</last_name>
    <phone>9012876303</phone>
    <email>sshah7@uthsc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kanwaljeet S Anand, MBBS, FCCM</last_name>
    <phone>9012876303</phone>
    <email>kanand@uthsc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Tennessee Health Sciences Center / Le Bonheur Children's Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samir H Shah, MBBS FRCPC</last_name>
      <phone>901-287-6303</phone>
      <email>sshah7@uthsc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kanwaljeet S Anand, MBBS FCCM</last_name>
      <phone>9012876303</phone>
      <email>kanand@uthsc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Samir H Shah, MBBS FRCPC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.uthsc.edu/pediatrics/criticalcare/</url>
    <description>UTHSC/Le Bonheur Children's Hospital Pediatric Critical Care Medicine Program</description>
  </link>
  <reference>
    <citation>Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.</citation>
    <PMID>15636651</PMID>
  </reference>
  <reference>
    <citation>Oliveira CF, Nogueira de Sa FR, Oliveira DS, Gottschald AF, Moura JD, Shibata AR, Troster EJ, Vaz FA, Carcillo JA. Time- and fluid-sensitive resuscitation for hemodynamic support of children in septic shock: barriers to the implementation of the American College of Critical Care Medicine/Pediatric Advanced Life Support Guidelines in a pediatric intensive care unit in a developing world. Pediatr Emerg Care. 2008 Dec;24(12):810-5. doi: 10.1097/PEC.0b013e31818e9f3a.</citation>
    <PMID>19050666</PMID>
  </reference>
  <reference>
    <citation>Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6. Erratum In: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].</citation>
    <PMID>19325359</PMID>
  </reference>
  <reference>
    <citation>Kissoon N, Orr RA, Carcillo JA. Updated American College of Critical Care Medicine--pediatric advanced life support guidelines for management of pediatric and neonatal septic shock: relevance to the emergency care clinician. Pediatr Emerg Care. 2010 Nov;26(11):867-9. doi: 10.1097/PEC.0b013e3181fb0dc0.</citation>
    <PMID>21057288</PMID>
  </reference>
  <reference>
    <citation>Cruz AT, Perry AM, Williams EA, Graf JM, Wuestner ER, Patel B. Implementation of goal-directed therapy for children with suspected sepsis in the emergency department. Pediatrics. 2011 Mar;127(3):e758-66. doi: 10.1542/peds.2010-2895. Epub 2011 Feb 21.</citation>
    <PMID>21339277</PMID>
  </reference>
  <reference>
    <citation>Coba V, Whitmill M, Mooney R, Horst HM, Brandt MM, Digiovine B, Mlynarek M, McLellan B, Boleski G, Yang J, Conway W, Jordan J; (The Henry Ford Hospital Sepsis Collaborative Group). Resuscitation bundle compliance in severe sepsis and septic shock: improves survival, is better late than never. J Intensive Care Med. 2011 Sep-Oct;26(5):304-13. doi: 10.1177/0885066610392499. Epub 2011 Jan 10.</citation>
    <PMID>21220270</PMID>
  </reference>
  <reference>
    <citation>Nguyen HB, Corbett SW, Steele R, Banta J, Clark RT, Hayes SR, Edwards J, Cho TW, Wittlake WA. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med. 2007 Apr;35(4):1105-12. doi: 10.1097/01.CCM.0000259463.33848.3D.</citation>
    <PMID>17334251</PMID>
  </reference>
  <reference>
    <citation>Larosa JA, Ahmad N, Feinberg M, Shah M, Dibrienza R, Studer S. The use of an early alert system to improve compliance with sepsis bundles and to assess impact on mortality. Crit Care Res Pract. 2012;2012:980369. doi: 10.1155/2012/980369. Epub 2012 Feb 26.</citation>
    <PMID>22461981</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Tennessee</investigator_affiliation>
    <investigator_full_name>Samir H. Shah</investigator_full_name>
    <investigator_title>Associate Professor, Department of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Systemic Inflammatory Response Syndrome (SIRS)</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Severe Sepsis</keyword>
  <keyword>Septic Shock</keyword>
  <keyword>Electronic Health Record</keyword>
  <keyword>Health Screening</keyword>
  <keyword>Goal Directed Therapy</keyword>
  <keyword>Infant</keyword>
  <keyword>Child</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Critical Illness</keyword>
  <keyword>Outcomes Research</keyword>
  <keyword>Resource Utilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Systemic Inflammatory Response Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT01724463
org study id: eASSIST-M
nct id: NCT01724463
lead sponsor: 
has dmc: No
Thousands of children die from Sepsis following routine infections. Many of these deaths can
      be prevented with earlier recognition and focused management. No tools are currently
      available to recognize the signs of early sepsis in children. The investigators have
      developed a electronic health record-based tool that will recognize children with sepsis
      early and trigger an alert to their hospital caregivers. The caregivers will be prompted to
      launch a focused management bundle that can stabilize these children, prevent further
      deterioration and reduce their chances of sepsis related complications and death. The
      proposed study will test the validity and effectiveness of this electronic tool in reducing
      sepsis mortality rates.
Project: Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool
      and Management Bundle (eASSIST-M) Study

      Study Type: Prospective Cohort Outcomes Study

      Background: Early recognition of severe sepsis is critical for the institution of goal-
      directed therapy and for improving patient outcomes. Barriers to early recognition include
      the lack of standardized tools to identify children with severe sepsis. The investigators
      will study the potential impact of applying a novel Pediatric Severe Sepsis Screening Tool
      (PSSST) integrated with the Electronic Health Record (EHR) to facilitate earlier detection
      and effective management of severe sepsis.

      Population: Patients between the ages 1 month and 18 years admitted to the hospital or
      presenting to the Emergency Department (ED) with clinical signs of Systemic Inflammatory
      Response Syndrome (SIRS).

      Primary Hypothesis: Prospective application of a PSSST electronically integrated with the EHR
      can accurately diagnose pediatric patients with early signs of severe sepsis.

      Primary Outcome Measure: Proportion of correctly diagnosed patients with severe sepsis among
      those presenting with SIRS will be assessed to prospectively validate the sensitivity,
      specificity, positive and negative predictive values of the PSSST tool.

      Secondary Hypothesis 1: Application of the PSSST will reduce lag-time for the administration
      of a goal-directed sepsis therapy bundle by 50%.

      Outcome Measure: Time delay from diagnostic identification to critical therapeutic
      intervention. Sepsis Recognition Lag Time will be defined as the time elapsed from the first
      electronic alert to the first therapeutic intervention. Therapeutic interventions will be
      defined as Cardiopulmonary Resuscitation (CPR), fluid resuscitation, initiation of
      cardiotonic agents, or request for transfer to the ICU. Since this is an intent-to-diagnose
      study, outcomes defined above will be compared with those for the same period in the
      preceding year.

      Secondary Hypothesis 2: Application of a severe sepsis management bundle will reduce
      mortality and morbidity.

      Outcome Measure: Proportion of deaths in the study population due to severe sepsis. Morbidity
      will be defined as the number of ventilator days, days on vasopressor or inotropic agents,
      days of Extracorporeal Membrane Oxygenation (ECMO) support, need for tracheostomy, need for
      Gastrostomy tube.

      Proposed Study Design:

      The investigators will conduct a prospective study where patients within the ED and inpatient
      units are electronically screened using the PSSST during a 3-year study period. Patients will
      be screened using a novel electronic tracking tool designed locally, using pre-defined severe
      sepsis variables and validated on patients with severe sepsis. Patients screened as positive
      for severe sepsis using the electronic tracking tool will be treated prospectively with a
      standardized severe sepsis management bundle. Data will be collected prospectively on all
      patients admitted to the ED and inpatient units. For the ED and each inpatient unit, the
      outcomes defined above will be compared with those for the same period in the preceding year.

      Covariates: Demographic, clinical characteristics and sepsis-specific factors that could
      potentially influence the effect of the alerts on critical intervention.

      Statistical Analysis:

      To assess the effectiveness of this tool, we will compare the proportions of the population
      with each variable of interest between the intervention and prior periods.

        1. To assess the efficacy of the PSSST, we will compare the changes over time in the
           proportion of patients diagnosed severe sepsis adjusting for key covariates of interest.

        2. To assess the effectiveness of the PSSST in reducing treatment delays, we will compare
           changes in the Sepsis Recognition Lag Time between the intervention and control periods,
           while adjusting for key covariates of interest.

        3. To assess the efficacy of the PSSST in reducing mortality, we will compare the changes
           in the age and risk adjusted mortality rates over time between the intervention and
           control periods.

      The investigators will use a robust variance estimate for all analyses to account for the
      clustering of patients within units. We will also use propensity scores to control for
      differences in patient characteristics and diagnostic categories.
observational model: Cohort
time perspective: Prospective
measure: Validity of the Pediatric Severe Sepsis Screening Tool
time frame: Average 60 days - Patients will be followed up until hospital discharge
description: Proportion of correctly diagnosed patients with severe sepsis among those presenting with SIRS will be assessed to prospectively validate the sensitivity, specificity, positive and negative predictive values of the PSSST tool.
measure: Time delay from diagnostic identification to critical therapeutic intervention in patients with Severe Sepsis.
time frame: Average 60 days - Patients will be followed up until hospital discharge
description: Sepsis Recognition Lag Time will be defined as the time elapsed from the first electronic alert to the first therapeutic intervention. Therapeutic interventions will be defined as Cardiopulmonary Resuscitation (CPR), fluid resuscitation, initiation of cardiotonic agents, or request for transfer to the ICU. Since this is an intent-to-diagnose study, outcomes defined above will be compared with those for the same period in the preceding year.
measure: Morbidity and Mortality Rates from Severe Sepsis
time frame: Average 60 days - Patients will be followed up until hospital discharge
description: Morbidity will be defined as the number of ventilator days, days on vasopressor or inotropic agents, days of Extracorporeal Membrane Oxygenation (ECMO) support, need for tracheostomy, need for Gastrostomy tube. Mortality will be defined as the proportion of deaths in children with severe sepsis.
arm group label: Electronically Screened Sepsis Patients
description: Patients between the ages 1 month and 18 years admitted to the hospital or presenting to the Emergency Department (ED) with clinical signs of Systemic Inflammatory Response Syndrome (SIRS) electronically screened for severe sepsis. Patients screened as positive will receive an evidence based goal directed severe sepsis management bundle.
intervention type: Other
intervention name: Severe Sepsis Management Bundle
description: Management Bundle includes:
Securing Intravenous Access
Obtaining Blood Culture
Antibiotic Administration
Goal Directed Fluid Bolus Therapy
Oxygen Administration
Measuring Serum Lactate Levels
arm group label: Electronically Screened Sepsis Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: Samir H Shah, MBBS MBA
role: Principal Investigator
affiliation: University of Tennessee Health Sciences Center
last name: Kanwaljeet S Anand, MBBS FCCM
role: Study Director
affiliation: University of Tennessee Health Sciences Center
last name: Samir H Shah, MBBS, MBA
phone: 9012876303
email: sshah7@uthsc.edu
last name: Kanwaljeet S Anand, MBBS, FCCM
phone: 9012876303
email: kanand@uthsc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: http://www.uthsc.edu/pediatrics/criticalcare/
description: UTHSC/Le Bonheur Children's Hospital Pediatric Critical Care Medicine Program
citation: Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
PMID: 15636651
citation: Oliveira CF, Nogueira de Sa FR, Oliveira DS, Gottschald AF, Moura JD, Shibata AR, Troster EJ, Vaz FA, Carcillo JA. Time- and fluid-sensitive resuscitation for hemodynamic support of children in septic shock: barriers to the implementation of the American College of Critical Care Medicine/Pediatric Advanced Life Support Guidelines in a pediatric intensive care unit in a developing world. Pediatr Emerg Care. 2008 Dec;24(12):810-5. doi: 10.1097/PEC.0b013e31818e9f3a.
PMID: 19050666
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responsible party type: Principal Investigator
investigator affiliation: University of Tennessee
investigator full name: Samir H. Shah
investigator title: Associate Professor, Department of Pediatrics
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic
mesh term: Systemic Inflammatory Response Syndrome