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Adrenal Exhaustion Syndrome in Critically Ill Patients Without Improvement
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, February 2008
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00674284
  Purpose

We study the relationship between patient outcomes and sequential changes of serum cortisol level.


Condition
Survival

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Epinephrine Epinephrine bitartrate
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Retrospective
Official Title: Change of Serum Cortisol Levels in Patients Without Improvement in Intensive Care Unit

Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Elevated corticosteroid level to meet physiologic needs during acute illness is a protective response for stress. This homeostasis is maintained by the hypothalamic-pituitary-adrenal (HPA) axis. However, inadequate response as corticosteroid insufficiency in critically ill patients is reported with increasing frequency, especially in severe sepsis and septic shock. Thus, corticosteroids could be beneficial for septic shock or severe acute illness.

Once considered as normal adrenal function, adrenal insufficiency may developed later with chronic critical illness as adrenal exhaustion syndrome. It is easily overlooked and is possible due to the chronic secretion of systemic cytokines or other HPA axis-suppressive substances. There is still no consensus how often adrenal function testing should be repeated, although a re-evaluation should be considered if clinical symptoms and signs suggest adrenal insufficiency or deteriorating clinical condition.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All of the adult patients (age >18 years) admitted to the intensive care units of the National Taiwan University Hospital between January 2005 and December 2006 were surveyed.

Criteria

Inclusion Criteria:

  • age over 18
  • ICU admission
  • had two cortisol data

Exclusion Criteria:

  • first cortisol data abnormal
  • cortisol data not checked in ICU
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674284

Locations
Taiwan
Chao-Chi Ho Recruiting
Taipei, Taiwan, 100
Contact: Chao-Chi Ho, PhD     886-2-2356-2905     ccho1203@ntu.edu.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Chao-Chi Ho, MD 1. Department of Internal Medicine, National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital ( Chao-Chi Ho )
Study ID Numbers: 200802022R
Study First Received: May 5, 2008
Last Updated: May 5, 2008
ClinicalTrials.gov Identifier: NCT00674284  
Health Authority: Taiwan: Department of Health

Study placed in the following topic categories:
Hydrocortisone
Cortisol succinate
Critical Illness
Hydrocortisone acetate
Epinephrine

ClinicalTrials.gov processed this record on January 16, 2009