Skip to main content
OpenTrials
Completed

NCT Number: NCT01143129

Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiac Surgery Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Utrecht

Utrecht, 3543CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On-pump coronary artery bypass graft (CABG)

Exclusion criteria

  • age < 18 years
  • preexisting cardiac rhythm disturbances

Treatment and study plan

Dexamethasone

Drug

Single dose (1 mg/kg) at start of cardiac surgical procedure

Placebo

Drug

Placebo solution in a comparable amount to the experimental drug (0.05 mL/kg)

Primary outcomes

  1. Atrial fibrillation

    Time frame: 5 days (postoperatively)

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: An Explanatory Study of the Prophylactic Effect of Corticosteroids (DECS-PNAF Project)

Acronym: DECS-PNAF

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 14, 2010
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.