NCT01670383

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2006Dec 2028

Study Start

First participant enrolled

July 1, 2006

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

22.4 years

First QC Date

August 8, 2012

Last Update Submit

November 21, 2023

Conditions

Cardiac ArrestSepsis

Keywords

Cardiac ArrestSepsisBiological MarkersAnti-Inflammation AgentsAntioxidants

Outcome Measures

Primary Outcomes (1)

  • 1-month mortality

    All cause mortality within 1-month

    1 month

Secondary Outcomes (3)

  • Hospital mortality

    until hospital discharge, an expected average of 2 weeks

  • ICU length of stay

    Until ward transfer or discharge, an expected average of 7 days

  • Favorable neurologic outcome

    at discharge, an expected average of 2 weeks and at 6-month

Study Arms (2)

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 Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sepsis patients admitted to ICU Postresuscitation patients admitted to ICU

You may qualify if:

  • 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

You may not qualify if:

  • refusal to participate
  • DNAR status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (5)

  • Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

    PMID: 11445675BACKGROUND

  • Dombrovskiy VY, Martin AA, Sunderram J, Paz HL. Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit Care Med. 2007 May;35(5):1244-50. doi: 10.1097/01.CCM.0000261890.41311.E9.

    PMID: 17414736BACKGROUND

  • Cohen J. The immunopathogenesis of sepsis. Nature. 2002 Dec 19-26;420(6917):885-91. doi: 10.1038/nature01326.

    PMID: 12490963BACKGROUND

  • Schneider A, Bottiger BW, Popp E. Cerebral resuscitation after cardiocirculatory arrest. Anesth Analg. 2009 Mar;108(3):971-9. doi: 10.1213/ane.0b013e318193ca99.

    PMID: 19224811BACKGROUND

  • Kim KS, Suh GJ, Jin M, Kwon WY, Jung YS, Kim T, Kim YT, Kim H, Park H. SECRETED TRYPTOPHANYL-tRNA SYNTHETASE 1 IS A PROGNOSTIC MARKER IN SEPSIS PATIENTS WITHOUT MONOCYTOPENIA. Shock. 2024 Jan 1;61(1):55-60. doi: 10.1097/SHK.0000000000002259. Epub 2023 Oct 20.

    PMID: 37878497DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients sera at ICU admission, day-1, day-3 and day-7 are stored in deep freezer.

MeSH Terms

Conditions

Heart ArrestSepsis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gil Joon Suh, Professor

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Kyung Su Kim, MD, PhD

CONTACT

82-10-8033-1127kanesu@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 22, 2012

Study Start

July 1, 2006

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

KR(1)