Adrenal Insufficiency in Septic Shock | NCT00842933

Studies
Adrenal Insufficiency in Septic Shock

NCT00842933

Sponsor

The Methodist Hospital Research Institute

Status

Terminated

Last Update Posted

Jun 29, 2011Estimated

Enrollment

32Estimated

Phase

Phase 4

Conditions

Septic Shock
Acute Adrenal Insufficiency

Interventions

Corticosteroid
Corticosteroid

Countries

United States

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to meet enrollment goal prior to PI transfer

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2010Actual

Completion Date

May 2011Actual

First Submitted Date

Feb 11, 2009

First Submission Date that Met QC Criteria

Feb 11, 2009

First Posted Date

Feb 12, 2009Estimated

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

Jun 28, 2011

Last Update Posted Date

Jun 29, 2011Estimated

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

Randomized controlled trial evaluating the duration of steroid replacement therapy in patients with adrenal insufficiency and septic shock. Patients will be randomized to receive either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50 mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP > 65 mm Hg off of vasopressors).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental	Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.	Drug: Corticosteroid
Standard of care group	Active Comparator	Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.	Drug: Corticosteroid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Corticosteroid	Drug	Cessation of corticosteroids 24 hours after cessation of vasopressors	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure for this study is the number of hours receiving steroid dosing.		7 days

Secondary Outcomes

Measure	Description	Time Frame
A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.		up to 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are 18 years of age or older
Patients who sign informed consent or are represented by a legally authorized representative to provide consent on behalf of the patient
Patients with septic shock meeting the ACCM/SCCM consensus conference definitions for septic shock

Exclusion Criteria:

Patients with documented allergic or anaphylactic reactions to corticosteroids
Patients who have received steroid therapy within 6 months of presentation
Patients who have received steroids during their hospital admission, with the exception of a single dose of dexamethasone
Patients who have received etomidate in the preceding 12 hours
Patients who have had a prior adrenalectomy or a known history of adrenal disease (documented adrenal insufficiency or Cushing syndrome).
Documented Human Immunodeficiency Virus (HIV) infection
Pregnancy
Allergies to adrenocorticotropic hormone (ACTH) or corticosteroids
Administration of additional medications which may suppress the hypothalamic-pituitary axis:
- Ketoconazole
- Aminoglutethimide
- Mitotane
- Megestrol acetate
- Suramin

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

Not provided

Sampling Method

Not provided

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

ID	Term
D000305	Adrenal Cortex Hormones
D011241	Prednisone

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D011244	Pregnadienediols
D011245	Pregnadienes