Repository for Sepsis and Postresuscitation Samples

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Gil Joon Suh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01670383
First received: August 8, 2012
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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
Cardiac Arrest
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Repository for Samples Collected From Sepsis and Postresuscitation Patients in Emergency Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 1-month mortality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    All cause mortality within 1-month


Secondary Outcome Measures:
  • Hospital mortality [ Time Frame: until hospital discharge, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    All cause mortality during hospitalization

  • ICU length of stay [ Time Frame: Until ward transfer or discharge, an expected average of 7 days ] [ Designated as safety issue: No ]
  • Favorable neurologic outcome [ Time Frame: at discharge, an expected average of 2 weeks and at 6-month ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 500
Study Start Date: July 2006
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

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
Study First Received: August 8, 2012
Last Updated: September 11, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014