The Ohio State University Sepsis Registry
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Purpose
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.
| Condition |
|---|
|
Sepsis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Ohio State University Sepsis Registry |
- To collect follow-up information about patients with sepsis in the OSUMC MICU who survive to hospital discharge for future retrospective IRB-approved studies. [ Time Frame: end of study ] [ Designated as safety issue: No ]
- To collect a blood sample from patients with sepsis admitted to the OSUMC MICU for future retrospective IRB-approved studies. [ Time Frame: end of study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood
| Estimated Enrollment: | 1500 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
sepsis
sepsis survivors
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
hospital intensive care unit
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Naeem Ali, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00837421 History of Changes |
| Other Study ID Numbers: | 2005H0029 |
| Study First Received: | February 4, 2009 |
| Last Updated: | February 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
sepsis registry |
Additional relevant MeSH terms:
|
Sepsis Toxemia Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013