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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J.M. Dieleman, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01143129
First received: June 11, 2010
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Cardiac Surgery
Drug: Dexamethasone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: An Explanatory Study of the Prophylactic Effect of Corticosteroids (DECS-PNAF Project)

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Atrial fibrillation [ Time Frame: 5 days (postoperatively) ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexamethasone
Single dose of dexamethasone (1 mg/kg) at the start of the cardiac surgical procedure
Drug: Dexamethasone
Single dose (1 mg/kg) at start of cardiac surgical procedure
Placebo Comparator: Placebo Drug: Placebo
Placebo solution in a comparable amount to the experimental drug (0.05 mL/kg)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On-pump coronary artery bypass graft (CABG)

Exclusion Criteria:

  • age < 18 years
  • preexisting cardiac rhythm disturbances
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143129

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3543CX
Sponsors and Collaborators
UMC Utrecht
  More Information

No publications provided

Responsible Party: J.M. Dieleman, Anesthesiologist in training, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01143129     History of Changes
Other Study ID Numbers: DECS-PNAF
Study First Received: June 11, 2010
Last Updated: February 21, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Atrial fibrillation
Cardiac surgery
Cardiopulmonary bypass
New-onset

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014