The Ohio State University Sepsis Registry

Study Overview
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Brief Summary
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Specific Aim #1: To collect follow-up information about patients with sepsis in the OSUMC MICU who survive to hospital discharge for future retrospective IRB-approved studies. Specific Aim #2: To collect a registry of patients who would be interested in hearing more information about future prospective IRB-approved studies for survivors of sepsis. Specific Aim #3: To collect a blood sample from patients with sepsis admitted to the OSUMC MICU for future retrospective IRB-approved studies.

Detailed Description
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There are several goals of the Ohio State University Sepsis Registry and Blood Bank. First, we hope that, by collecting a cohort of patients with sepsis, we will provide information for future studies with data of specific relevance to sepsis (the Clinical Registry). Second, by following survivors of sepsis for a more prolonged period than prior studies, we will better understand the disease process and the duration of recovery (the Follow-up Registry). We will contact hospital survivors every six months to assess their vital status, living situation and employment. Furthermore, subjects will have the opportunity to find out about new studies as they arise. Finally, we will ask subjects for permission to collect a blood sample (10 cc) to use for future studies analyzing genetic and protein data. There will be a step-wise consent process that will allow subjects to opt out of any or all parts of the study.

Official Title
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The Ohio State University Sepsis Registry

Conditions
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Sepsis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to OSUMC MICU, ≥ 18 years, have consensus criteria for sepsis (infection plus two of four systemic inflammatory response syndrome [SIRS] signs [tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia]). Exclusion Criteria: Consent not available or declined, prisoner, died before discharge (excluded from Follow-up Registry only), died before blood collected (excluded from Blood Bank only), onset of sepsis more than 24 hours prior to ICU admission. Patients who have sepsis onset more than 24 hours prior to ICU admission but spent the ENTIRETY of the current admission in the OSUMC ED will be eligible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sepsis<br>sepsis survivors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect follow-up information about patients with sepsis in the OSUMC MICU who survive to hospital discharge for future retrospective IRB-approved studies. |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect a blood sample from patients with sepsis admitted to the OSUMC MICU for future retrospective IRB-approved studies. |  | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, registry