Comparing an Automated to a Conventional Sepsis Clinical Prediction Rule

Sepsis Clinical Trial

Official title:

Comparing an Automated to a Conventional Sepsis Clinical Prediction Rule

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01505478
• Other study ID #: 2011P000356
• Status: Withdrawn
• Phase: N/A
• First received: January 4, 2012
• Last updated: April 4, 2017
• Start date: July 2012

Study information

• Verified date: January 2012
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will conduct a prospective cohort study to compare an automated sepsis severity score to a conventional clinical prediction rule to risk stratify patients admitted from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All consecutive adult (age 18 or older) Emergency Department (ED) patients during the study period that have been admitted from the ED and identified by the treating clinician to have a suspected infection at the time of ED disposition will comprise our study population.

Exclusion Criteria:

• No patients will be excluded from the study.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	New York University, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day in-hospital mortality	The primary endpoint is the AUC of a model to predict 28 day all cause in-hospital mortality. Patients discharged or transferred to another hospital before 28 days will be assumed to be alive at 28 days.
Secondary	ICU Admission	The secondary endpoint is ICU admission from the ED or within 24 hours from the floor.