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

Tracking Information

First Received Date ^ICMJE

August 30, 2007

Last Updated Date

December 8, 2008

Start Date ^ICMJE

February 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00523198 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Septic Shock

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients with septic shock

Exclusion Criteria:

Corticosteroid replacement
Blood in mouth

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00523198

Responsible Party

Rosa M. Estrada-Y-Martin, University of Texas - Health Science Center at Houston

Study ID Numbers ^ICMJE

HSC-MS-06-413, M01-RR 02558 (GCRC)

Study Sponsor ^ICMJE

The University of Texas Health Science Center, Houston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Rosa M Estrada-Y-Martin, MD

The University of Texas-Health Science Center at Houston / Division of Pulmonary, Sleep and Critical Care Medicine

Information Provided By

The University of Texas Health Science Center, Houston

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP