Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project (DECS-PNAF)
Primary Purpose
Atrial Fibrillation, Cardiac Surgery
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiac surgery, Cardiopulmonary bypass, New-onset
Eligibility Criteria
Inclusion Criteria:
- On-pump coronary artery bypass graft (CABG)
Exclusion Criteria:
- age < 18 years
- preexisting cardiac rhythm disturbances
Sites / Locations
- University Medical Center Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dexamethasone
Placebo
Arm Description
Single dose of dexamethasone (1 mg/kg) at the start of the cardiac surgical procedure
Outcomes
Primary Outcome Measures
Atrial fibrillation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01143129
Brief Title
Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project
Acronym
DECS-PNAF
Official Title
Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: An Explanatory Study of the Prophylactic Effect of Corticosteroids (DECS-PNAF Project)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect cardiac surgical patients from Postoperative New-onset Atrial Fibrillation (PNAF). Patients will be randomized to receive either a single high dose of dexamethasone or a placebo. Continuous ECG-monitoring, echocardiography and biochemical and genomic analyses will be used to investigate the mechanisms responsible for the known protective effect of corticosteroids in the development of PNAF.
Detailed Description
Postoperative new-onset atrial fibrillation (PNAF) is a common complication after cardiac surgery, affecting up to 60% of patients. PNAF has been associated with a higher incidence of adverse postoperative outcomes including long-term mortality, and leads to an increased use of resources and higher social costs.
Many studies have investigated potential determinants of PNAF. Established determinants can grossly be divided into inflammatory factors, cardiac functional (echographic) parameters, cardiac electrophysiologic properties and other (demographic) risk factors. Also, a substantial number of studies have investigated pharmacological prophylactic strategies. In these studies, the highest effectiveness has been shown for strategies involving either betablockers, statins and, more recently, corticosteroids.
The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect cardiac surgical patients from PNAF. The modulating effect of intraoperative prophylactic high-dose dexamethasone administration on the categories of perioperative determinants of PNAF mentioned above will be studied in 164 coronary artery bypass grafting surgery patients. For this, multiple perioperative assessments will be performed using, for example, repeated biochemical assessment of inflammation, genomic analysis of (mainly inflammatory) single nucleotide polymorphisms, continuous electrocardiographic (Holter) monitoring and transesophageal echocardiography.
The DECS-PNAF project is one of the first prospective studies to combine a detailed assessment of multiple categories of PNAF determinants. Moreover, it is unique in studying the effect of prophylactic corticosteroid administration on every one of these determinants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiac Surgery
Keywords
Atrial fibrillation, Cardiac surgery, Cardiopulmonary bypass, New-onset
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexamethasone
Arm Type
Experimental
Arm Description
Single dose of dexamethasone (1 mg/kg) at the start of the cardiac surgical procedure
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Single dose (1 mg/kg) at start of cardiac surgical procedure
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo solution in a comparable amount to the experimental drug (0.05 mL/kg)
Primary Outcome Measure Information:
Title
Atrial fibrillation
Time Frame
5 days (postoperatively)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On-pump coronary artery bypass graft (CABG)
Exclusion Criteria:
age < 18 years
preexisting cardiac rhythm disturbances
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3543CX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project
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