Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest

Heart Arrest Clinical Trial

Official title:

Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00172354
• Other study ID #: 930502
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 30, 2012
• Start date: October 2004
• Est. completion date: May 2006

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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. 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>

1. 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

2. 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

3. 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

4. Smithline H, Rivers E, Appleton T, Nowak R.;"Corticosteroid supplementation during cardiac arrest in rats."Resuscitation 1993;25:257-64

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Drug:
• Hydrocortisone

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,