Salivary Cortisol in Intensive Care Unit | NCT02001207

Studies
Salivary Cortisol in Intensive Care Unit

NCT02001207

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 20, 2014Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Critically Ill

Interventions

Salivary cortisol test

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

Nov 27, 2013

First Submission Date that Met QC Criteria

Nov 27, 2013

First Posted Date

Dec 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2014

Last Update Posted Date

Nov 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Label	Type	Description	Intervention Names
MICU patients			Other: Salivary cortisol test

Name	Type	Description	Arm Group Labels	Other Names
Salivary cortisol test	Other		MICU patients

Measure	Description	Time Frame
Overall mortality		28 days

Measure	Description	Time Frame
ICU days		28 days
ventilator-free days		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who agreed to participate

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinwoo Lee, M.D.	Contact			realrain7@gmail.com

Overall Officials

Name	Affiliation	Role
Sang-Min Lee	Seoul National University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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