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OpenTrials
Completed

NCT Number: NCT00523198

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 with septic shock and, * that salivary cortisol correlates with free serum cortisol and can be used to determine the level of free serum cortisol.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas- Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with septic shock

Exclusion criteria

  • Corticosteroid replacement
  • Blood in mouth

Treatment and study plan

Primary outcomes

  1. Salivary cortisol

    Time frame: one year

    salivary cortisol in mg/dL

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 31, 2007
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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