Systemic Inflammatory Response Syndrome (SIRS)eASSIST-MNCT01724463
Electronic Application of a Severe Sepsis Screening Tool and Management Bundle
An observational study of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis
- What is being tested?
- Severe Sepsis Management Bundle
- Type of treatment
- Injection or infusion
- How many people
- 30,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- Age 1 month - 18 years
- Clinical Suspicion of Infection
- Patients in the Hospital or Emergency Department
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Health Sciences Center / Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Samir H Shah, MBBS FRCPC, 901-287-6303, sshah7@uthsc.edu
Kanwaljeet S Anand, MBBS FCCM, 9012876303, kanand@uthsc.edu
About this study
Official title: Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle Study to Improve Sepsis Related Outcomes
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.
Read the detailed description
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.
- 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.
- 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.
- 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.
- Being tested
- Severe Sepsis Management Bundle
- 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
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Shock, Septic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe Sepsis Management BundleOther
Management Bundle includes:
- Securing Intravenous Access
- Obtaining Blood Culture
- Antibiotic Administration
- Goal Directed Fluid Bolus Therapy
- Oxygen Administration
- Measuring Serum Lactate Levels
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Severe Sepsis Management Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Average 60 days - Patients will be followed up until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response Syndrome (SIRS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir H. Shah, University of Tennessee
- Investigators
- Samir H Shah, MBBS MBA, Principal investigator, University of Tennessee Health Sciences CenterKanwaljeet S Anand, MBBS FCCM, Study director, University of Tennessee Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724463
- Sponsor's protocol ID
- eASSIST-M
- Acronym
- eASSIST-M
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2012
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15636651Oliveira 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.
PubMed 19050666Brierley 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.
PubMed 19325359Kissoon 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.
PubMed 21057288Cruz 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.
PubMed 21339277Coba 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.
PubMed 21220270Nguyen 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.
PubMed 17334251Larosa 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.
PubMed 22461981
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle Study to Improve Sepsis Related Outcomes
- ClinicalTrials.gov ID
- NCT01724463
- Acronym / sponsor ID
- eASSIST-M / eASSIST-M
- Keywords
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock, Electronic Health Record, Health Screening, Goal Directed Therapy, Infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronically Screened Sepsis Patients | – | Other: Severe Sepsis Management BundlePatients 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (3 listed)
- Age 1 month - 18 years
- Clinical Suspicion of Infection
- Patients in the Hospital or Emergency Department
Key exclusion criteria (6 listed)
- Status Asthmaticus patients on active bronchodilator therapy
- Patients receiving Anesthesia
- Day Surgery Patients
- Outpatient Clinic Patients
- Congenital Heart Disease Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Severe Sepsis Management BundleManagement 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 | Other | Electronically Screened Sepsis Patients |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Background: PubMed 15636651Goldstein 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.
- Background: PubMed 19050666Oliveira 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.
- Background: PubMed 19325359Brierley 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.
- Background: PubMed 21057288Kissoon 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.
- Background: PubMed 21339277Cruz 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.
- Background: PubMed 21220270Coba 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.
- Background: PubMed 17334251Nguyen 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.
- Background: PubMed 22461981Larosa 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.
- UTHSC/Le Bonheur Children's Hospital Pediatric Critical Care Medicine ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir H Shah, MBBS MBA principal investigator
University of Tennessee Health Sciences Center
Kanwaljeet S Anand, MBBS FCCM study director
University of Tennessee Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samir H Shah, MBBS, MBA (9012876303, sshah7@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the Pediatric Severe Sepsis Screening Tool (time frame: Average 60 days - Patients will be followed up until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724463, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.