Cardiac ArrestNCT01670383
Repository for Sepsis and Postresuscitation Samples
An observational study of Cardiac Arrest and Sepsis, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiac Arrest, Sepsis
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2006to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sepsis patients admitted to ICU Postresuscitation patients admitted to ICU
Who may be able to join
- 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
Who cannot join
- refusal to participate
- DNAR status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Kyung Su Kim, MD, PhD
Kyung Su Kim, MD, PhD
About this study
Official title: 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.
- Conditions
- Cardiac Arrest, Sepsis
- Keywords
- Cardiac Arrest, Sepsis, Biological Markers, Anti-Inflammation Agents, Antioxidants
- Medical subject headings
- Heart Arrest, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
1-month mortality
All cause mortality within 1-month
Measured: 1 month
Secondary outcomes (3)
Hospital mortality
All cause mortality during hospitalization
Measured: until hospital discharge, an expected average of 2 weeks
ICU length of stay
Measured: Until ward transfer or discharge, an expected average of 7 days
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.
Measured: at discharge, an expected average of 2 weeks and at 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJul 2006
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Joon Suh, Seoul National University Hospital
- Investigators
- Gil Joon Suh, Professor, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670383
- Sponsor's protocol ID
- SNUHEM-Repository-12-0001
- Status last verified
- Nov 2023
- First submitted
- 8 Aug 2012
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11445675Dombrovskiy 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.
PubMed 17414736Cohen J. The immunopathogenesis of sepsis. Nature. 2002 Dec 19-26;420(6917):885-91. doi: 10.1038/nature01326.
PubMed 12490963Schneider A, Bottiger BW, Popp E. Cerebral resuscitation after cardiocirculatory arrest. Anesth Analg. 2009 Mar;108(3):971-9. doi: 10.1213/ane.0b013e318193ca99.
PubMed 19224811Kim 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.
PubMed 37878497
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repository for Samples Collected From Sepsis and Postresuscitation Patients in Emergency Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01670383
- Acronym / sponsor ID
- SNUHEM-Repository-12-0001
- Conditions
- Cardiac Arrest, Sepsis
- Keywords
- Cardiac Arrest, Sepsis, Biological Markers, Anti-Inflammation Agents, Antioxidants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sepsis patients admitted to ICU Postresuscitation patients admitted to ICU
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- refusal to participate
- DNAR status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-month mortality
Time frame: 1 month
All cause mortality within 1-month
3 secondary outcomes
Hospital mortality
Time frame: 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
Favorable neurologic outcome
Time frame: at discharge, an expected average of 2 weeks and at 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 11445675Angus 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.
- Background: PubMed 17414736Dombrovskiy 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.
- Background: PubMed 12490963Cohen J. The immunopathogenesis of sepsis. Nature. 2002 Dec 19-26;420(6917):885-91. doi: 10.1038/nature01326.
- Background: PubMed 19224811Schneider A, Bottiger BW, Popp E. Cerebral resuscitation after cardiocirculatory arrest. Anesth Analg. 2009 Mar;108(3):971-9. doi: 10.1213/ane.0b013e318193ca99.
- Derived from this study: PubMed 37878497Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gil Joon Suh, Professor study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Sepsis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyung Su Kim, MD, PhD (82-10-8033-1127, kanesu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-month mortality (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670383, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.