The aim of this project is to elucidate how corticosteroids protect cardiac surgical patients from PNAF. We will therefore examine the modulating effect of prophylactic high-dose corticosteroid administration on perioperative risk factors for PNAF.…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative new-onset atrial fibrillation
Secondary outcome
Mortality
Myocardial infarction
Myocardial necrosis (cardiac enzymes)
Stroke
Renal failure
Prolonged mechanical ventilation
Cardiac arrhythmias other than atrial fibrillation
Use of inotropes on the first postoperative day
Use of anti-anginal drugs
Wound infection
Any infection requiring the use of systemic antibiotics
Length of stay in the intensive care unit and in the hospital
Background summary
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. 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.
Study objective
The aim of this project is to elucidate how corticosteroids protect cardiac
surgical patients from PNAF. We will therefore examine the modulating effect of
prophylactic high-dose corticosteroid administration on perioperative risk
factors for PNAF. In this project, the focus is on 3 groups of PNAF risk
factors:
- Inflammation related
- Atrial (pump) function related
- Conduction related
Study design
Subjects can only participate in the DECS-PNAF project, if they are also
included in the DExamethasone for Cardiac Surgery (DECS) trial. In the DECS
trial, cardiac surgical patients are randomized between a single intraoperative
injection of dexamethasone 1 mg/kg of placebo. For the DECS-PNAF project,
multiple assessments will be performed in the perioperative period using, for
example, repeated biochemical assessment of inflammation, continuous
electrocardiographic (Holter) monitoring, transesophageal echocardiography and
analysis of several single nucleotide polymorphisms (SNPs).
Intervention
Dexamethasone 1 mg/kg of placebo as a single injection at the beginning of the
surgical procedure.
Study burden and risks
The extra burden the that participant will experience are almost exclusively
the Holter electrocardiography monitoring and daily temperature measurements,
which are non-invasive and a minimal physical burden. Sampling of blood and
tissue are confined to either the intraoperative period or regular blood
sampling timepoints, as such not causing extra burden tot the participant.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Patients who are scheduled to undergo coronary artery bypass grafting, aortic valve surgery, or a combination of both (without concomitant other valve surgery or other additional procedures), who are participating in the DECS trial are eligible for inclusion in the DECS-PNAF project.
Exclusion criteria
Patients with a history of atrial fibrillation, as well as patients not in sinus rhythm preoperatively, are not eligible for inclusion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01143129 |
| CCMO | NL33200.041.10 |