Recruiting

Observational Study

Sponsor:

University of Tennessee

Code:

NCT01724463

Conditions

Systemic Inflammatory Response Syndrome (SIRS)

Sepsis

Severe Sepsis

Septic Shock

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Severe Sepsis Management Bundle

Study Details

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

Study ID

NCT01724463

Start date

Mar, 2013

Status verified date

Mar, 2015

Completion date

Oct, 2018

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Validity of the Pediatric Severe Sepsis Screening Tool [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ]

Central Contacts and Locations

Central contacts

Samir H Shah, MBBS, MBA

9012876303sshah7@uthsc.edu

Kanwaljeet S Anand, MBBS, FCCM

9012876303kanand@uthsc.edu

Locations

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

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Samir H Shah, MBBS FRCPC

901-287-6303sshah7@uthsc.edu

Kanwaljeet S Anand, MBBS FCCM

9012876303kanand@uthsc.edu

Principal Investigator:

Samir H Shah, MBBS FRCPC

More Information

Sponsor

University of Tennessee

Last update posted

Mar 31, 2015

Last verified

Mar, 2015

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2015-03-31.