Repository for Sepsis and Postresuscitation Samples

March 16, 2021 updated by: Gil Joon Suh, Seoul National University Hospital

Repository for Samples Collected From Sepsis and Postresuscitation Patients in Emergency Intensive Care Unit

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kyung Su Kim, MD, PhD
  • Phone Number: 82-10-8033-1127
  • Email: kanesu@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sepsis patients admitted to ICU Postresuscitation patients admitted to ICU

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-month mortality
Time Frame: 1 month
All cause mortality within 1-month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: until hospital discharge, an expected average of 2 weeks
All cause mortality during hospitalization
until hospital discharge, an expected average of 2 weeks
ICU length of stay
Time Frame: Until ward transfer or discharge, an expected average of 7 days
Until ward transfer or discharge, an expected average of 7 days
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.
at discharge, an expected average of 2 weeks and at 6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Gil Joon Suh, Professor, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 19, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUHEM-Repository-12-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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