Atrial FibrillationNCT00442494
Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery
A study testing intravenous hydrocortisone in people with Atrial Fibrillation, run by Kuopio University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- intravenous hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled.
Who cannot join
- Previous episodes of AF or flutter
- Uncontrolled diabetes mellitus
- Systemic mycotic infection
- Active tuberculosis
- Cushing's syndrome
- Psychotic mental disorder
Show all 9Show fewer
- Herpes Simplex keratitis
- Serum creatinine exceeding 200 µg/ml
- Patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis.
About this study
Official title: Feasibility of Corticosteroid in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Prospective, Double-Blind Randomized Multicenter Trial
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.
- Conditions
- Atrial Fibrillation
- Being tested
- intravenous hydrocortisone
- Keywords
- Atrial fibrillation after cardiac surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous hydrocortisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Study couldn´t start due to investigator | Other | Study couldn´t start due to investigator Receives: Drug: intravenous hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Measured: Study couldn´t start due to investigator
Secondary outcomes (1)
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Measured: Study couldn´t start due to investigator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startOct 2012
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Study has been completed as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Oulu University Hospital
- Responsible party
- Principal investigator, Helena Pehkonen, Kuopio University Hospital
- Investigators
- Jari Halonen, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442494
- Sponsor's protocol ID
- KUH5204515
- Status last verified
- Oct 2012
- First submitted
- 1 Mar 2007
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17426276Halonen J, Halonen P, Jarvinen O, Taskinen P, Auvinen T, Tarkka M, Hippelainen M, Juvonen T, Hartikainen J, Hakala T. Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1562-7. doi: 10.1001/jama.297.14.1562.
PubMed 17426275
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Corticosteroid in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Prospective, Double-Blind Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT00442494
- Acronym / sponsor ID
- KUH5204515
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation after cardiac surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been completed as planned
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Oulu University Hospital
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study couldn´t start due to investigator | Other | Drug: intravenous hydrocortisoneStudy couldn´t start due to investigator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled.
Key exclusion criteria (9 listed)
- Previous episodes of AF or flutter
- Uncontrolled diabetes mellitus
- Systemic mycotic infection
- Active tuberculosis
- Cushing's syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous hydrocortisone | Drug | Study couldn´t start due to investigator |
Primary outcome
Study couldn´t start due to investigator
Time frame: Study couldn´t start due to investigator
Study couldn´t start due to investigator
1 secondary outcome
Study couldn´t start due to investigator
Time frame: Study couldn´t start due to investigator
Results and safety
The study was stopped early (reason given: Study has been completed as planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
- Derived from this study: PubMed 17426276Voltarelli 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.
- Derived from this study: PubMed 17426275Halonen J, Halonen P, Jarvinen O, Taskinen P, Auvinen T, Tarkka M, Hippelainen M, Juvonen T, Hartikainen J, Hakala T. Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1562-7. doi: 10.1001/jama.297.14.1562.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Halonen, MD principal investigator
Kuopio University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing intravenous hydrocortisone in people with Atrial Fibrillation, run by Kuopio University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study has been completed as planned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study couldn´t start due to investigator (time frame: Study couldn´t start due to investigator). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00442494, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012.