Cardiopulmonary ResuscitationNCT00173615
Extracorporeal Membrane Oxygenation Effect in Prolonged Cardiopulmonary Resuscitation
An observational study of Cardiopulmonary Resuscitation and Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Analysis of the patients' data who were rescued with extracorporeal membrane oxygenation and without ECMO. The survival rate and the weaning rate were analyzed to see the effect of ECMO on the prolonged CPR. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiopulmonary Resuscitation, Cardiac Arrest, Ventricular Tachycardia
- What is being tested?
- Extracorporeal membrane oxygenation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 1996to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CPR > 10 min without return of spontaneous circulation
Who cannot join
- CPR with traumatic origin unless bleeding was under control, previous irreversible brain damage, terminal status of malignancy, and the age over 75 years. For the patients with post-cardiotomy shock requiring ECLS in the operating theater because of an inability of weaning from cardiopulmonary bypass, they were excluded as well from this ECPR cohort since they did not receive cardiac massage. The patients that had signed "Do-Not-Resuscitate" (DNR) consent were also excluded from ECLS deployment.
Trial locations and contacts
1 site in 1 country.
About this study
Analysis of the patients' data who were rescued with extracorporeal membrane oxygenation and without ECMO. The survival rate and the weaning rate were analyzed to see the effect of ECMO on the prolonged CPR.
- Conditions
- Cardiopulmonary Resuscitation, Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Extracorporeal membrane oxygenation
- Keywords
- ECMO, CPR
- Medical subject headings
- Heart Arrest, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal membrane oxygenationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 1996
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yih-Sharng Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173615
- Sponsor's protocol ID
- 9461700820
- Status last verified
- Jan 2009
- First submitted
- 12 Sep 2005
- Last updated
- 19 Jan 2009
- Results posted
- No
Publications
KOUWENHOVEN WB, JUDE JR, KNICKERBOCKER GG. Closed-chest cardiac massage. JAMA. 1960 Jul 9;173:1064-7. doi: 10.1001/jama.1960.03020280004002. No abstract available.
PubMed 14411374Eisenberg MS, Mengert TJ. Cardiac resuscitation. N Engl J Med. 2001 Apr 26;344(17):1304-13. doi: 10.1056/NEJM200104263441707. No abstract available.
PubMed 11320390Bedell SE, Delbanco TL, Cook EF, Epstein FH. Survival after cardiopulmonary resuscitation in the hospital. N Engl J Med. 1983 Sep 8;309(10):569-76. doi: 10.1056/NEJM198309083091001.
PubMed 6877286Cooper S, Janghorbani M, Cooper G. A decade of in-hospital resuscitation: outcomes and prediction of survival? Resuscitation. 2006 Feb;68(2):231-7. doi: 10.1016/j.resuscitation.2005.06.012. Epub 2005 Dec 1.
PubMed 16325314Weil MH, Fries M. In-hospital cardiac arrest. Crit Care Med. 2005 Dec;33(12):2825-30. doi: 10.1097/01.ccm.0000191265.20007.9d.
PubMed 16352966Chen YS, Chao A, Yu HY, Ko WJ, Wu IH, Chen RJ, Huang SC, Lin FY, Wang SS. Analysis and results of prolonged resuscitation in cardiac arrest patients rescued by extracorporeal membrane oxygenation. J Am Coll Cardiol. 2003 Jan 15;41(2):197-203. doi: 10.1016/s0735-1097(02)02716-x.
PubMed 12535808Cummins RO, Chamberlain D, Hazinski MF, Nadkarni V, Kloeck W, Kramer E, Becker L, Robertson C, Koster R, Zaritsky A, Bossaert L, Ornato JP, Callanan V, Allen M, Steen P, Connolly B, Sanders A, Idris A, Cobbe S. Recommended guidelines for reviewing, reporting, and conducting research on in-hospital resuscitation: the in-hospital 'Utstein style'. American Heart Association. Circulation. 1997 Apr 15;95(8):2213-39. doi: 10.1161/01.cir.95.8.2213. No abstract available.
PubMed 9133537Tunstall-Pedoe H, Bailey L, Chamberlain DA, Marsden AK, Ward ME, Zideman DA. Survey of 3765 cardiopulmonary resuscitations in British hospitals (the BRESUS Study): methods and overall results. BMJ. 1992 May 23;304(6838):1347-51. doi: 10.1136/bmj.304.6838.1347.
PubMed 1611332Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
PubMed 9824069Chen YS, Lin JW, Yu HY, Ko WJ, Jerng JS, Chang WT, Chen WJ, Huang SC, Chi NH, Wang CH, Chen LC, Tsai PR, Wang SS, Hwang JJ, Lin FY. Cardiopulmonary resuscitation with assisted extracorporeal life-support versus conventional cardiopulmonary resuscitation in adults with in-hospital cardiac arrest: an observational study and propensity analysis. Lancet. 2008 Aug 16;372(9638):554-61. doi: 10.1016/S0140-6736(08)60958-7. Epub 2008 Jul 4.
PubMed 18603291
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation Effect in Prolonged Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT00173615
- Acronym / sponsor ID
- 9461700820
- Conditions
- Cardiopulmonary Resuscitation, Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- Keywords
- ECMO, CPR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 1996
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Sep 2005 (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.
Analysis of the patients' data who were rescued with extracorporeal membrane oxygenation and without ECMO. The survival rate and the weaning rate were analyzed to see the effect of ECMO on the prolonged CPR.
Study design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CPR > 10 min without return of spontaneous circulation
Key exclusion criteria (1 listed)
- CPR with traumatic origin unless bleeding was under control, previous irreversible brain damage, terminal status of malignancy, and the age over 75 years. For the patients with post-cardiotomy shock requiring ECLS in the operating theater because of an inability of weaning from cardiopulmonary bypass, they were excluded as well from this ECPR cohort since they did not receive cardiac massage. The patients that had signed "Do-Not-Resuscitate" (DNR) consent were also excluded from ECLS deployment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal membrane oxygenation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2009.
- Background: PubMed 14411374KOUWENHOVEN WB, JUDE JR, KNICKERBOCKER GG. Closed-chest cardiac massage. JAMA. 1960 Jul 9;173:1064-7. doi: 10.1001/jama.1960.03020280004002. No abstract available.
- Background: PubMed 11320390Eisenberg MS, Mengert TJ. Cardiac resuscitation. N Engl J Med. 2001 Apr 26;344(17):1304-13. doi: 10.1056/NEJM200104263441707. No abstract available.
- Background: PubMed 6877286Bedell SE, Delbanco TL, Cook EF, Epstein FH. Survival after cardiopulmonary resuscitation in the hospital. N Engl J Med. 1983 Sep 8;309(10):569-76. doi: 10.1056/NEJM198309083091001.
- Background: PubMed 16325314Cooper S, Janghorbani M, Cooper G. A decade of in-hospital resuscitation: outcomes and prediction of survival? Resuscitation. 2006 Feb;68(2):231-7. doi: 10.1016/j.resuscitation.2005.06.012. Epub 2005 Dec 1.
- Background: PubMed 16352966Weil MH, Fries M. In-hospital cardiac arrest. Crit Care Med. 2005 Dec;33(12):2825-30. doi: 10.1097/01.ccm.0000191265.20007.9d.
- Background: PubMed 12535808Chen YS, Chao A, Yu HY, Ko WJ, Wu IH, Chen RJ, Huang SC, Lin FY, Wang SS. Analysis and results of prolonged resuscitation in cardiac arrest patients rescued by extracorporeal membrane oxygenation. J Am Coll Cardiol. 2003 Jan 15;41(2):197-203. doi: 10.1016/s0735-1097(02)02716-x.
- Background: PubMed 9133537Cummins RO, Chamberlain D, Hazinski MF, Nadkarni V, Kloeck W, Kramer E, Becker L, Robertson C, Koster R, Zaritsky A, Bossaert L, Ornato JP, Callanan V, Allen M, Steen P, Connolly B, Sanders A, Idris A, Cobbe S. Recommended guidelines for reviewing, reporting, and conducting research on in-hospital resuscitation: the in-hospital 'Utstein style'. American Heart Association. Circulation. 1997 Apr 15;95(8):2213-39. doi: 10.1161/01.cir.95.8.2213. No abstract available.
- Background: PubMed 1611332Tunstall-Pedoe H, Bailey L, Chamberlain DA, Marsden AK, Ward ME, Zideman DA. Survey of 3765 cardiopulmonary resuscitations in British hospitals (the BRESUS Study): methods and overall results. BMJ. 1992 May 23;304(6838):1347-51. doi: 10.1136/bmj.304.6838.1347.
- Background: PubMed 9824069Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
- Derived from this study: PubMed 18603291Chen YS, Lin JW, Yu HY, Ko WJ, Jerng JS, Chang WT, Chen WJ, Huang SC, Chi NH, Wang CH, Chen LC, Tsai PR, Wang SS, Hwang JJ, Lin FY. Cardiopulmonary resuscitation with assisted extracorporeal life-support versus conventional cardiopulmonary resuscitation in adults with in-hospital cardiac arrest: an observational study and propensity analysis. Lancet. 2008 Aug 16;372(9638):554-61. doi: 10.1016/S0140-6736(08)60958-7. Epub 2008 Jul 4.
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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. This study is not recruiting at the moment.
Yih-Sharng Chen, MD, PhD principal investigator
National Taiwan 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 Cardiopulmonary Resuscitation and Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jan 2009. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00173615, which also lists 10 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 19 Jan 2009.