A Study of the Accuracy of Physician Diagnosis of Sepsis Prior to Objective Testing
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-000676
Sponsor Protocol Number: 14-000676
About this study
The purpose of this study is to determine the accuracy and clinical usefulness of a physicians impression prior to having objective laboratory data or imaging results for the diagnosis of sepsis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- We will include physician encounters with patients that meet any one of the following four criteria and the providers will be blinded to the reason
- Two SIRS criteria and systolic blood pressure < 90 mmHg
- Two SIRS criteria and blood cultures ordered
- Two SIRS criteria and an elevated lactate (physician input will only be measured if not aware of the lactate result)
- Systolic blood pressure < 90 mmHg and blood cultures ordered
Exclusion Criteria
- We will exclude children and pregnant women since the cardiovascular responses to infection differ among these groups
- We will also exclude prisoners and vulnerable adults
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available