Correlation Salivary Cortisol and Free Serum Cortisol to Total Serum Cortisol in MICU 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...

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

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