Heart ArrestNCT00172354
Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
A study testing Hydrocortisone in people with Heart Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Out-of-hospital cardiac arrest (OHCA) is an important issue for the emergency physicians and co-workers. How to improve the return of spontaneous circulation (ROSC) rate and prognosis of these patients challenges the emergency team. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Hydrocortisone
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2004to May 2006
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-of-hospital cardiac arrest
Who cannot join
- pregnancy
- younger than 18 years old
- trauma
- concurrent steroid use
- ECMO use in resuscitation
- allergy to steroid
Trial locations and contacts
1 site in 1 country.
About this study
Out-of-hospital cardiac arrest (OHCA) is an important issue for the emergency physicians and co-workers. How to improve the return of spontaneous circulation (ROSC) rate and prognosis of these patients challenges the emergency team. When encounters stress, the hypothalamus of human releases corticotropin releasing hormone, which in turn stimulates the pituitary gland to release ACTH. Then ACTH acts on the adrenal gland to release glucocorticoid to against stress. Foley PJ et al found the dogs with bilateral adrenalectomy had lower ROSC rate during resuscitation than those without surgery[1]. Karl H. Linder et al showed OHCA patients had high serum vasopressin and ACTH level but low serum cortisol level. Besides, the serum cortisol level had a negative correlation with collapse duration (no CPR duration)[2]. Studies also revealed the successfully resuscitated patients had higher serum ACTH and cortisol level than non-resuscitated ones[2,3]. In addition, the serum cortisol level was found to be correlated with short term survival rate and hemodynamic status in resuscitated OHCA patients[3]. Animal study also showed mice receiving higher dosage of hydrocortisone had higher ROSC rate and lower epinephrine requirement than those receiving lower dosage of hydrocortisone or normal saline.
<Reference>
- Foley PJ, Tacker WA, Wortsman J, Frank S, Cryer PE.;" Plasma catecholamine and serum cortisol responses to experimental cardiac arrest in dogs."Am J Physiol 1987;253:E283-9
- Lindner KH, Strohmenger HU, Ensinger H, Hetzel WD, Ahnefeld FW, Georgieff M.;" Stress hormone response during and after cardiopulmonary resuscitation."Anesthesiology 1992;77:662-8
- Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman J, Nowak RM.;"A characterization of hypothalamic-pituitary-adrenal axis function during and after human cardiac arrest."Crit Care Med 1993;21:1339-47
- Smithline H, Rivers E, Appleton T, Nowak R.;"Corticosteroid supplementation during cardiac arrest in rats."Resuscitation 1993;25:257-64
- Conditions
- Heart Arrest
- Being tested
- Hydrocortisone
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
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 startOct 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Jone Chen, PhD, Study director, Chiarman of NTUH emergency department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172354
- Sponsor's protocol ID
- 930502
- Status last verified
- Nov 2012
- First submitted
- 12 Sep 2005
- Last updated
- 3 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00172354
- Acronym / sponsor ID
- 930502
- Conditions
- Heart Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- May 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.
Out-of-hospital cardiac arrest (OHCA) is an important issue for the emergency physicians and co-workers. How to improve the return of spontaneous circulation (ROSC) rate and prognosis of these patients challenges the emergency team. When encounters stress, the hypothalamus of human releases corticotropin releasing hormone, which in turn stimulates the pituitary gland to release ACTH. Then ACTH acts on the adrenal gland to release glucocorticoid to against stress. Foley PJ et al found the dogs with bilateral adrenalectomy had lower ROSC rate during resuscitation than those without surgery[1]. Karl H. Linder et al showed OHCA patients had high serum vasopressin and ACTH level but low serum cortisol level. Besides, the serum cortisol level had a negative correlation with collapse duration (no CPR duration)[2]. Studies also revealed the successfully resuscitated patients had higher serum ACTH and cortisol level than non-resuscitated ones[2,3]. In addition, the serum cortisol level was found to be correlated with short term survival rate and hemodynamic status in resuscitated OHCA patients[3]. Animal study also showed mice receiving higher dosage of hydrocortisone had higher ROSC rate and lower epinephrine requirement than those receiving lower dosage of hydrocortisone or normal saline.
<Reference>
- Foley PJ, Tacker WA, Wortsman J, Frank S, Cryer PE.;" Plasma catecholamine and serum cortisol responses to experimental cardiac arrest in dogs."Am J Physiol 1987;253:E283-9
- Lindner KH, Strohmenger HU, Ensinger H, Hetzel WD, Ahnefeld FW, Georgieff M.;" Stress hormone response during and after cardiopulmonary resuscitation."Anesthesiology 1992;77:662-8
- Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman J, Nowak RM.;"A characterization of hypothalamic-pituitary-adrenal axis function during and after human cardiac arrest."Crit Care Med 1993;21:1339-47
- Smithline H, Rivers E, Appleton T, Nowak R.;"Corticosteroid supplementation during cardiac arrest in rats."Resuscitation 1993;25:257-64
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Out-of-hospital cardiac arrest
Key exclusion criteria (6 listed)
- pregnancy
- younger than 18 years old
- trauma
- concurrent steroid use
- ECMO use in resuscitation
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 |
|---|---|---|
| Hydrocortisone | Drug | – |
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 3 Dec 2012.
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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.
Wen-Jone Chen, PhD study director
Chiarman of NTUH emergency department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone in people with Heart 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 6 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 3 Dec 2012. 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?
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 3 Dec 2012.