Prospective Study on the Incidence of Adrenal Crisis in P... | NCT01184209

Studies
Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency

NCT01184209

Sponsor

University of Wuerzburg

Status

Completed

Last Update Posted

Jan 6, 2014Estimated

Enrollment

444Actual

Phase

Not provided

Conditions

Adrenal Insufficiency

Interventions

Not provided

Countries

Germany

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

Jan 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 2007

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 17, 2010

First Posted Date

Aug 18, 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

Jan 3, 2014

Last Update Posted Date

Jan 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bruno Allolio, MD, University of WuerzburgPrincipal Investigator

Lead Sponsor

University of WuerzburgOTHER

Collaborators

Name	Class
Ludwig-Maximilians - University of Munich	OTHER
Charite University, Berlin, Germany	OTHER

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

Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis in patients with chronic adrenal insufficiency.

Detailed Description

This is a prospective study following patients with chronic adrenal insufficiency by contacting them every 6 months via questionnaires and telephone. QUestionnaires assess incidence and causes of adrenal crisis, frequency of hospitalization.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

444Actual

Measure	Description	Time Frame
incidence of adrenal crisis		during study period

Measure	Description	Time Frame
mortality		during study period

Measure	Description	Time Frame
hospital admission		during study period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic primary or secondary adrenal insufficiency requiring glucocorticoid substitution therapy

Exclusion Criteria:

adrenocortical carcinoma
long term glucocorticoid treatment above 7.5 mg prednisone equivalent dose for other reasons than adrenal insufficiency
age < 18 years

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

adult patients with chronic secondary or primary adrenal failure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Allolio, MD	University of Wuerzburg	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Berlin		Berlin		D-10117	Germany
University of Wuerzburg

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25419882	Derived	Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.

ID	Term
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases