Salivary Cortisol in Intensive Care Unit

November 18, 2014 updated by: Seoul National University Hospital

Association of Salivary Cortisol Levels and Outcome of Critically Ill Patients in the Intensive Care Unit

In critical illness, patients are highly stressed and should have elevated cortisol (stress hormone) secretion to adapt to stress. Dysfunction of this system is referred to as critical illness-related corticosteroid insufficiency. Free cortisol (unbound form) which is mainly responsible for its physiologic function is difficult to measure. We hypothesized that the salivary cortisol, which can be obtained by noninvasive methods, can more accurately evaluate adrenal function of critically ill patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the intensive care unit in Seoul National University Hospital

Description

Inclusion Criteria:

  • patients who agreed to participate

Exclusion Criteria:

  • Known adrenal or pituitary disease
  • oral bleeding
  • currently on systemic or inhaled corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MICU patients
Other: Salivary cortisol test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU days
Time Frame: 28 days
28 days
ventilator-free days
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Sang-Min Lee, Seoul National University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1304-072-482

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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