Septic ShockNCT00523198
Correlation Salivary Cortisol and Free Serum Cortisol to Total Serum Cortisol in MICU Septic Shock
An observational study of Septic Shock, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is: to correlate salivary cortisol to free serum cortisol (as salivary cortisol is considered to be almost complete free cortisol) and, to correlate free serum cortisol to total serum cortisol levels Both in patients with septic shock (severe sepsis requiring vasopressors). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 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: MICU patients with septic shock
Who may be able to join
- Adult patients with septic shock
Who cannot join
- Corticosteroid replacement
- Blood in mouth
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas- Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Correlation Between Salivary Cortisol and Free Serum Cortisol Compared to Total Serum Cortisol in MICU Patients With Septic Shock
The purpose of the study is:
- to correlate salivary cortisol to free serum cortisol (as salivary cortisol is considered to be almost complete free cortisol) and,
- to correlate free serum cortisol to total serum cortisol levels
Both in patients with septic shock (severe sepsis requiring vasopressors).
We believe that:
- total serum cortisol does not correlate with free serum cortisol in patient with septic shock and,
- that salivary cortisol correlates with free serum cortisol and can be used to determine the level of free serum cortisol.
Read the detailed description
Free serum cortisol is considered the active hormone.
In patients with septic shock only the total serum cortisol level is available, however, the free cortisol level can be normal despite a low total cortisol level due to changes in the serum protein.
The hormone can be replaced improperly in these patients and contribute to poor outcome in septic shock.
We are studying adult MICU patients with septic shock who are not receiving corticosteroid replacement.
This study does not include any intervention.
In-hospital or 28-day mortality are registered in all the patients.
- Conditions
- Septic Shock
- Keywords
- Cortisol
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol
salivary cortisol in mg/dL
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startFeb 2007
- Primary completionAug 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Estrada Y Martin, The University of Texas Health Science Center, Houston
- Investigators
- Rosa M Estrada-Y-Martin, MD, Principal investigator, The University of Texas-Health Science Center at Houston / Division of Pulmonary, Sleep and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523198
- Sponsor's protocol ID
- HSC-MS-06-413
- Other IDs
- M01-RR 02558 (GCRC), M01RR002558
- Status last verified
- Dec 2014
- First submitted
- 30 Aug 2007
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Estrada-Y-Martin RM, Orlander PR. Salivary cortisol can replace free serum cortisol measurements in patients with septic shock. Chest. 2011 Nov;140(5):1216-1222. doi: 10.1378/chest.11-0448. Epub 2011 Aug 4.
PubMed 21816912
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Salivary Cortisol and Free Serum Cortisol Compared to Total Serum Cortisol in MICU Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT00523198
- Acronym / sponsor ID
- HSC-MS-06-413
- Conditions
- Septic Shock
- Keywords
- Cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 31 Aug 2007 (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.
The purpose of the study is:
- to correlate salivary cortisol to free serum cortisol (as salivary cortisol is considered to be almost complete free cortisol) and,
- to correlate free serum cortisol to total serum cortisol levels
Both in patients with septic shock (severe sepsis requiring vasopressors).
We believe that:
- total serum cortisol does not correlate with free serum cortisol in patient with septic shock and,
- that salivary cortisol correlates with free serum cortisol and can be used to determine the level of free serum cortisol.
Detailed description
Free serum cortisol is considered the active hormone.
In patients with septic shock only the total serum cortisol level is available, however, the free cortisol level can be normal despite a low total cortisol level due to changes in the serum protein.
The hormone can be replaced improperly in these patients and contribute to poor outcome in septic shock.
We are studying adult MICU patients with septic shock who are not receiving corticosteroid replacement.
This study does not include any intervention.
In-hospital or 28-day mortality are registered in all the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MICU patients with septic shock
Key inclusion criteria (1 listed)
- Adult patients with septic shock
Key exclusion criteria (2 listed)
- Corticosteroid replacement
- Blood in mouth
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
Salivary cortisol
Time frame: one year
salivary cortisol in mg/dL
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 4 Dec 2014.
- Derived from this study: PubMed 21816912Estrada-Y-Martin RM, Orlander PR. Salivary cortisol can replace free serum cortisol measurements in patients with septic shock. Chest. 2011 Nov;140(5):1216-1222. doi: 10.1378/chest.11-0448. Epub 2011 Aug 4.
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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.
Rosa M Estrada-Y-Martin, MD principal investigator
The University of Texas-Health Science Center at Houston / Division of Pulmonary, Sleep and Critical Care Medicine
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 Septic Shock, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 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 4 Dec 2014. 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 United States. 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.
What does the primary outcome measure?
Salivary cortisol (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00523198, which also lists 1 linked publication.
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 4 Dec 2014.