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...
Date First Received: August 30, 2007
Last Updated: December 8, 2008
Verified by: The University of Texas Health Science Center, Houston, December 2008
Clinical Trial Phase: N/A | Start Date: February 2007
Overall Status: Completed
Estimated Enrollment: 60
Brief Summary
Official Title: “Correlation Between Salivary Cortisol and Free Serum Cortisol Compared to Total Serum Cortisol in MICU Patients With Septic Shock”
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Cohort, Prospective
Study Primary Completion Date: August 2008
Detailed Clinical Trial 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.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adult patients with septic shock
Exclusion Criteria:
- Corticosteroid replacement
- Blood in mouth
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: The University of Texas Health Science Center, Houston
Overall Clinical Trial Officials and Contacts
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
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00523198
Study ID Number: HSC-MS-06-413
ClinicalTrials.gov Identifier: NCT00523198
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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