Electronic Application of a Severe Sepsis Screening Tool and Management Bundle (eASSIST-M)
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|ClinicalTrials.gov Identifier: NCT01724463|
Recruitment Status : Recruiting
First Posted : November 9, 2012
Last Update Posted : March 31, 2015
|Condition or disease||Intervention/treatment|
|Systemic Inflammatory Response Syndrome (SIRS) Sepsis Severe Sepsis Septic Shock||Other: Severe Sepsis Management Bundle|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||30000 participants|
|Official Title:||Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle Study to Improve Sepsis Related Outcomes|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2018|
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:
- Validity of the Pediatric Severe Sepsis Screening Tool [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ]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.
- 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 ]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.
- Morbidity and Mortality Rates from Severe Sepsis [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724463
|Contact: Samir H Shah, MBBS, MBAemail@example.com|
|Contact: Kanwaljeet S Anand, MBBS, FCCMfirstname.lastname@example.org|
|United States, Tennessee|
|University of Tennessee Health Sciences Center / Le Bonheur Children's Hospital||Recruiting|
|Memphis, Tennessee, United States, 38103|
|Contact: Samir H Shah, MBBS FRCPC 901-287-6303 email@example.com|
|Contact: Kanwaljeet S Anand, MBBS FCCM 9012876303 firstname.lastname@example.org|
|Principal Investigator: Samir H Shah, MBBS FRCPC|
|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|