Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
Primary Purpose
Heart Arrest
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hydrocortisone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Arrest
Eligibility Criteria
Inclusion Criteria: Out-of-hospital cardiac arrest Exclusion Criteria: pregnancy younger than 18 years old trauma concurrent steroid use ECMO use in resuscitation allergy to steroid
Sites / Locations
- National Taiwan University Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00172354
First Posted
September 12, 2005
Last Updated
November 30, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00172354
Brief Title
Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
Official Title
Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Out-of-hospital cardiac arrest
Exclusion Criteria:
pregnancy
younger than 18 years old
trauma
concurrent steroid use
ECMO use in resuscitation
allergy to steroid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Jone Chen, PhD
Organizational Affiliation
Chiarman of NTUH emergency department
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
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