Electronic Application of a Severe Sepsis Screening Tool and Management Bundle (eASSIST-M)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Samir H. Shah, University of Tennessee
ClinicalTrials.gov Identifier:
NCT01724463
First received: October 31, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Systemic Inflammatory Response Syndrome (SIRS)
Sepsis
Severe Sepsis
Septic Shock
Other: Severe Sepsis Management Bundle

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle Study to Improve Sepsis Related Outcomes

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Validity of the Pediatric Severe Sepsis Screening Tool [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Morbidity and Mortality Rates from Severe Sepsis [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30000
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Electronically Screened Sepsis Patients
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.
Other: Severe Sepsis Management Bundle

Management Bundle includes:

  1. Securing Intravenous Access
  2. Obtaining Blood Culture
  3. Antibiotic Administration
  4. Goal Directed Fluid Bolus Therapy
  5. Oxygen Administration
  6. Measuring Serum Lactate Levels

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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).

Criteria

Inclusion Criteria:

  1. Age 1 month - 18 years
  2. Clinical Suspicion of Infection
  3. Patients in the Hospital or Emergency Department

Exclusion Criteria:

  1. Status Asthmaticus patients on active bronchodilator therapy
  2. Patients receiving Anesthesia
  3. Day Surgery Patients
  4. Outpatient Clinic Patients
  5. Congenital Heart Disease Patients
  6. Myocarditis Neonates Patients older than 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724463

Locations
United States, Tennessee
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Samir H Shah, MBBS MBA University of Tennessee Health Sciences Center
Study Director: Kanwaljeet S Anand, MBBS FCCM University of Tennessee Health Sciences Center
  More Information

Additional Information:
Publications:
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. Erratum in: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].

Responsible Party: Samir H. Shah, Associate Professor, Department of Pediatrics, University of Tennessee
ClinicalTrials.gov Identifier: NCT01724463     History of Changes
Other Study ID Numbers: eASSIST-M
Study First Received: October 31, 2012
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Tennessee:
Systemic Inflammatory Response Syndrome (SIRS)
Sepsis
Severe Sepsis
Septic Shock
Electronic Health Record
Health Screening
Goal Directed Therapy
Infant
Child
Pediatric
Adolescent
Critical Illness
Outcomes Research
Resource Utilization

Additional relevant MeSH terms:
Sepsis
Toxemia
Syndrome
Shock, Septic
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Disease
Shock

ClinicalTrials.gov processed this record on October 02, 2014