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NCT01670383 Clinical Trial

Repository for Sepsis and Postresuscitation Samples

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01670383
Other study ID # SNUHEM-Repository-12-0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2006
Est. completion date December 2028

Study information
Verified date November 2023
Source Seoul National University Hospital
Contact Kyung Su Kim, MD, PhD
Phone 82-10-8033-1127
Email kanesu@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

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

Outcome
Type Measure Description Time frame Safety issue
Primary 1-month mortality All cause mortality within 1-month 1 month
Secondary Hospital mortality All cause mortality during hospitalization until hospital discharge, an expected average of 2 weeks
Secondary ICU length of stay Until ward transfer or discharge, an expected average of 7 days
Secondary Favorable neurologic outcome 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
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