Prevention of Postoperative Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01742039
First received: November 14, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

The primary aim of this study is to determine the safest and most effective therapeutic strategy to decrease the incidence of postoperative atrial fibrillation following cardiac surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to evaluate the length of hospital stay associated with each treatment strategy.


Condition
Postoperative Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A New Therapeutic Strategy to Reduce the Incidence of Postoperative Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • occurrence of atrial fibrillation [ Time Frame: postoperative day 0-day of discharge (an average of 5 days) ] [ Designated as safety issue: No ]
    The primary endpoint of this study was also the occurrence of atrial fibrillation for any length of time requiring treatment as a result of symptoms or hemodynamic compromise.

  • occurrence of atrial fibrillation [ Time Frame: postoperative day 0-day of discharge (an average of 5 days) ] [ Designated as safety issue: No ]
    The primary endpoint of this study was the occurrence of atrial fibrillation lasting longer than five minutes


Secondary Outcome Measures:
  • length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
    The secondary endpoint was the length of hospital stay after surgery.


Enrollment: 160
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
b-blocker
amiodarone
atrial pacing
amiodarone plus atrial pacing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

adult patients undergoing open heart surgery

Criteria

Inclusion Criteria:

  • age > or = to 18 years
  • sinus rhythm
  • undergoing either coronary artery bypass graft surgery (CABG), valvular heart surgery or a combined procedure

Exclusion Criteria:

  • received a class-I or class-III antiarrhythmic agent in the past six months
  • had second or third degree heart block
  • had a resting heart rate of less than 50 beats per minute
  • had a systolic blood pressure less than 100 mmHg
  • had severe asthma or severe chronic obstructive pulmonary disease
  • had uncontrolled heart failure
  • had a serum aspartate aminotransferase or alanine aminotransferase concentration greater than four times the upper limit of normal
  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: NCT01742039

Locations
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
George Washington University Hospital
Washington DC, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
  More Information

No publications provided

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01742039     History of Changes
Other Study ID Numbers: AF01
Study First Received: November 14, 2012
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014