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NCT00523198 Clinical Trial

Correlation Salivary Cortisol and Free Serum Cortisol to Total Serum Cortisol in MICU Septic Shock

Septic Shock Clinical Trial

Official title:
Correlation Between Salivary Cortisol and Free Serum Cortisol Compared to Total Serum Cortisol in MICU Patients With Septic Shock

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00523198
Other study ID # HSC-MS-06-413
Secondary ID M01-RR 02558 (GC
Status Completed
Phase N/A
First received August 30, 2007
Last updated December 2, 2014
Start date February 2007
Est. completion date October 2008

Study information
Verified date December 2014
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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).

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients with septic shock

Exclusion Criteria:

- Corticosteroid replacement

- Blood in mouth

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States The University of Texas- Health Science Center at Houston Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Salivary cortisol salivary cortisol in mg/dL one year No
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