NCT00523198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

August 30, 2007

Last Update Submit

December 2, 2014

Conditions

Septic Shock

Keywords

Cortisol

Outcome Measures

Primary Outcomes (1)

  • Salivary cortisol

    salivary cortisol in mg/dL

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MICU patients with septic shock

You may qualify if:

  • Adult patients with septic shock

You may not qualify if:

  • Corticosteroid replacement
  • Blood in mouth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas- Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Estrada-Y-Martin RM, Orlander PR. Salivary cortisol can replace free serum cortisol measurements in patients with septic shock. Chest. 2011 Nov;140(5):1216-1222. doi: 10.1378/chest.11-0448. Epub 2011 Aug 4.

    PMID: 21816912DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Rosa M Estrada-Y-Martin, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

February 1, 2007

Primary Completion

August 1, 2008

Study Completion

October 1, 2008

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

US(1)