NCT02001207

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

November 20, 2014

Status Verified

December 1, 2013

Enrollment Period

1.9 years

First QC Date

November 27, 2013

Last Update Submit

November 18, 2014

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    28 days

Secondary Outcomes (2)

  • ICU days

    28 days

  • ventilator-free days

    28 days

Study Arms (1)

MICU patients

Other: Salivary cortisol test

Interventions

Salivary cortisol testOTHER
MICU patients

Eligibility Criteria

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

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

You may qualify if:

  • patients who agreed to participate

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sang-Min Lee

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinwoo Lee, M.D.

CONTACT

realrain7@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Last Updated

November 20, 2014

Record last verified: 2013-12

Locations

KR(1)