Electronic Application of a Severe Sepsis Screening Tool and Management Bundle

NCT01724463 | Unknown

• 1 other identifier: eASSIST-M
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Inflammatory Response Syndrome (SIRS); Sepsis; Severe Sepsis; Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Validity of the Pediatric Severe Sepsis Screening Tool

  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.

  Average 60 days - Patients will be followed up until hospital discharge

Secondary Outcomes (1)

• Time delay from diagnostic identification to critical therapeutic intervention in patients with Severe Sepsis.

  Average 60 days - Patients will be followed up until hospital discharge

Other Outcomes (1)

• Morbidity and Mortality Rates from Severe Sepsis

  Average 60 days - Patients will be followed up until hospital discharge

Study Arms (1)

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

Interventions

Severe Sepsis Management Bundle OTHER

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

Electronically Screened Sepsis Patients

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• Status Asthmaticus patients on active bronchodilator therapy
• Patients receiving Anesthesia
• Day Surgery Patients
• Outpatient Clinic Patients
• Congenital Heart Disease Patients
• Myocarditis Neonates Patients older than 18 years

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Sciences Center / Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19325359 BACKGROUND

• 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.

  PMID: 21057288 BACKGROUND

• 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.

  PMID: 21339277 BACKGROUND

• 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.

  PMID: 21220270 BACKGROUND

• 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.

  PMID: 17334251 BACKGROUND

• 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.

  PMID: 22461981 BACKGROUND

Related Links

• UTHSC/Le Bonheur Children's Hospital Pediatric Critical Care Medicine Program

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections; Disease Attributes

Study Officials

• Samir H Shah, MBBS MBA

  University of Tennessee Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Kanwaljeet S Anand, MBBS FCCM

  University of Tennessee Health Sciences Center

  STUDY DIRECTOR

Central Study Contacts

Samir H Shah, MBBS, MBA

CONTACT

9012876303; sshah7@uthsc.edu

Kanwaljeet S Anand, MBBS, FCCM

CONTACT

9012876303; kanand@uthsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 9, 2012
• Study Start: March 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (1)