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

Sponsor:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00523198

Purpose

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.

Condition
Septic Shock

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Correlation Between Salivary Cortisol and Free Serum Cortisol Compared to Total Serum Cortisol in MICU Patients With Septic Shock

Resource links provided by NLM:

MedlinePlus related topics: Shock

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Enrollment:	60
Study Start Date:	February 2007
Study Completion Date:	October 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MICU patients with septic shock

Criteria

Inclusion Criteria:

Adult patients with septic shock

Exclusion Criteria:

Corticosteroid replacement
Blood in mouth

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523198

Locations

United States, Texas
The University of Texas- Health Science Center at Houston
Houston, Texas, United States, 77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

More Information

No publications provided by The University of Texas Health Science Center, Houston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Estrada-Y-Martin RM, Orlander PR. Salivary cortisol can replace free serum cortisol measurements in patients with septic shock. Chest. 2011 Nov;140(5):1216-22. Epub 2011 Aug 4.

Responsible Party:	Rosa M. Estrada-Y-Martin, University of Texas - Health Science Center at Houston
ClinicalTrials.gov Identifier:	NCT00523198 History of Changes
Other Study ID Numbers:	HSC-MS-06-413, M01-RR 02558 (GCRC)
Study First Received:	August 30, 2007
Last Updated:	December 8, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Cortisol

Additional relevant MeSH terms:

Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012