The Effects of Hydrocortisone in Endotoxemia in Normal Vo... | NCT01064986

Studies
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

NCT01064986

Sponsor

Rutgers, The State University of New Jersey

Status

Completed

Last Update Posted

May 22, 2014Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Infections

Interventions

Endotoxin, Lipopolysaccharide, LPS
Endotoxin, Lipopolysaccharide, LPS /Epinephrine
Placebo
Hydrocortisone

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

ID	Type	Description	Link
NIH/DHHS	Other Grant/Funding Number	GM34695

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 5, 2010

First Submission Date that Met QC Criteria

Feb 8, 2010

First Posted Date

Feb 9, 2010Estimated

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

May 20, 2014

Last Update Posted Date

May 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a few hours. This study is designed to give hydrocortisone before and after Endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the Endotoxin.

Detailed Description

The body's immune response to injury otr infection is very complex. Immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Hydrocortisone is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study is designed to give hydrocortisone before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to hydrocortisone and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Placebo Comparator	IV Endotoxin plus saline vehicle (placebo)	Biological: Endotoxin, Lipopolysaccharide, LPS Biological: Placebo
B	Active Comparator	IV Endotoxin plus IV hydrocortisone	Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine Biological: Hydrocortisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endotoxin, Lipopolysaccharide, LPS	Biological	Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (~5 minutes)	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physiological, Hematological, Immunological Responses		0.5-24 hrs post Endotoxin administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

General good health as demonstrated by medical history, physical& laboratory tests
Age between 18 and 40 years
Written informed consent prior to the performance of any study related procedures

Exclusion Criteria:

History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
Any medication taken in past 48 hrs (except birth control)
Recent history of alcohol or drug abuse
Unable to provide written informed consent
Exposure to any experimental agent or procedure within 30 days of study
Pregnant or breast-feeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Siobhan Corbett, MD	Rutgers-RWJMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rutgers-RWJMS		New Brunswick	New Jersey	08901	United States

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004731	Endotoxins
D008070	Lipopolysaccharides
D012965	Sodium Chloride
D004837	Epinephrine
C007133	hydrocortisone hemisuccinate
D006854	Hydrocortisone

Ancestor Terms

ID	Term
D001427	Bacterial Toxins
D014118	Toxins, Biological
D001685	Biological Factors
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided