Corticosteroids for the Prevention of Atrial Fibrillation... | NCT00442494

Studies
Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT00442494

Sponsor

Kuopio University Hospital

Status

Terminated

Last Update Posted

Nov 16, 2012Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

intravenous hydrocortisone

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study has been completed as planned

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Mar 1, 2007

First Submission Date that Met QC Criteria

Mar 1, 2007

First Posted Date

Mar 2, 2007Estimated

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 15, 2012

Last Update Posted Date

Nov 16, 2012Estimated

Name	Class
Tampere University Hospital	OTHER
Oulu University Hospital	OTHER

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

Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery. Inflammatory response may be one etiological factor.

We hypothesized that intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study couldn´t start due to investigator	Other	Study couldn´t start due to investigator	Drug: intravenous hydrocortisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravenous hydrocortisone	Drug		Study couldn´t start due to investigator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study couldn´t start due to investigator	Study couldn´t start due to investigator	Study couldn´t start due to investigator

Secondary Outcomes

Measure	Description	Time Frame
Study couldn´t start due to investigator	Study couldn´t start due to investigator	Study couldn´t start due to investigator

Other Outcomes

Measure	Description	Time Frame
Study couldn´t start due to investigator	Study couldn´t start due to investigator	Study couldn´t start due to investigator

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled.

Exclusion Criteria:

Previous episodes of AF or flutter
Uncontrolled diabetes mellitus
Systemic mycotic infection
Active tuberculosis
Cushing's syndrome
Psychotic mental disorder
Herpes Simplex keratitis
Serum creatinine exceeding 200 µg/ml
Patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jari Halonen, MD	Kuopio University Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17426276	Derived	Voltarelli JC, Couri CE, Stracieri AB, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KC, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt RK. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007 Apr 11;297(14):1568-76. doi: 10.1001/jama.297.14.1568.
17426275

Type	Date	Date Unknown
Release	Nov 26, 2013
Reset	Jan 24, 2014
Release	Mar 5, 2018
Reset	Nov 1, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 26, 2013			Jan 24, 2014
Mar 5, 2018

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes