The Ohio State University Sepsis Registry

This study has suspended participant recruitment.
(Temporary hold on enrollment for interim analysis)
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00837421
First received: February 4, 2009
Last updated: February 8, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

hospital intensive care unit

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837421

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: James M O'Brien, MD Ohio State University
  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 August 21, 2014