SurvivalNCT00674284
Adrenal Exhaustion Syndrome in Critically Ill Patients Without Improvement
An observational study of Survival, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We study the relationship between patient outcomes and sequential changes of serum cortisol level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survival
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2008to May 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age over 18
- ICU admission
- had two cortisol data
Who cannot join
- first cortisol data abnormal
- cortisol data not checked in ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change of Serum Cortisol Levels in Patients Without Improvement in Intensive Care Unit
We study the relationship between patient outcomes and sequential changes of serum cortisol level.
Read the 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.
- Conditions
- Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivalStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chao-Chi Ho, MD, Study director, 1. Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674284
- Sponsor's protocol ID
- 200802022R
- Status last verified
- Nov 2009
- First submitted
- 5 May 2008
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Serum Cortisol Levels in Patients Without Improvement in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00674284
- Acronym / sponsor ID
- 200802022R
- Conditions
- Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 May 2008 (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.
We study the relationship between patient outcomes and sequential changes of serum cortisol level.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age over 18
- ICU admission
- had two cortisol data
Key exclusion criteria (2 listed)
- first cortisol data abnormal
- cortisol data not checked in ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 25 Nov 2009.
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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.
Chao-Chi Ho, MD study director
1. Department of Internal Medicine, 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 Survival, 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 3 inclusion and 2 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 25 Nov 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?
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 25 Nov 2009.