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Repository for Sepsis and Postresuscitation Samples

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ClinicalTrials.gov Identifier: NCT01670383
Recruitment Status : Recruiting
First Posted : August 22, 2012
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Gil Joon Suh, Seoul National University Hospital

Brief Summary:
The objective of this study is to find a new therapeutic strategy by investigating the serial serum samples of patients with sepsis or postresuscitation state.

Condition or disease
Cardiac Arrest Sepsis

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Repository for Samples Collected From Sepsis and Postresuscitation Patients in Emergency Intensive Care Unit
Study Start Date : July 2006
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Group/Cohort
Postresuscitation group
Adults (age over 16 years old) who have survived from nontraumatic cardiac arrest and admitted to ICU.
Sepsis group
Adults (age over 16 years old) who satisfy the sepsis criteria (SIRS>=2 and infection is suspected for a cause) and admitted to the ICU.



Primary Outcome Measures :
  1. 1-month mortality [ Time Frame: 1 month ]
    All cause mortality within 1-month


Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: until hospital discharge, an expected average of 2 weeks ]
    All cause mortality during hospitalization

  2. ICU length of stay [ Time Frame: Until ward transfer or discharge, an expected average of 7 days ]
  3. Favorable neurologic outcome [ Time Frame: at discharge, an expected average of 2 weeks and at 6-month ]

    Favorable neurologic outcome is used for outcome measure in postresuscitation patients only.

    Favorable neurologic outcome means cerebral performance category 1 and 2. This outcome is measured at discharge and 6-month after admission.



Biospecimen Retention:   Samples Without DNA
Patients sera at ICU admission, day-1, day-3 and day-7 are stored in deep freezer.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sepsis patients admitted to ICU Postresuscitation patients admitted to ICU
Criteria

Inclusion Criteria:

  • Age over 16 years old
  • Admitted to ICU
  • Diagnosed as having sepsis or as postresuscitation status
  • Definition of sepsis: 2 or more SIRS criteria + infection is suspected
  • Definition of postresuscitation status: Survived from non-traumatic cardiac arrest

Exclusion Criteria:

  • refusal to participate
  • DNAR status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670383


Contacts
Contact: Kyung Su Kim, MD, PhD 82-10-8033-1127 kanesu@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyung Su Kim, MD, PhD         
Sub-Investigator: Kyung Su Kim, MD, PhD         
Sub-Investigator: Woon Yong Kwon, MD, PhD         
Principal Investigator: Gil Joon Suh, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Gil Joon Suh, Professor Seoul National University Hospital

Publications:
Responsible Party: Gil Joon Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01670383     History of Changes
Other Study ID Numbers: SNUHEM-Repository-12-0001
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Gil Joon Suh, Seoul National University Hospital:
Cardiac Arrest
Sepsis
Biological Markers
Anti-Inflammation Agents
Antioxidants

Additional relevant MeSH terms:
Sepsis
Toxemia
Heart Arrest
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases