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Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127712
First Posted: August 8, 2005
Last Update Posted: September 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Purdue University
Information provided by (Responsible Party):
James E. Tisdale, Purdue University
Results First Submitted: March 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Intervention: Drug: Amiodarone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Amiodarone Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
Control Control group

Participant Flow:   Overall Study
    Amiodarone   Control
STARTED   65   65 
COMPLETED   60   65 
NOT COMPLETED   5   0 
Adverse Event                3                0 
Lack of GI access to continue                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Amiodarone Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
Control Control group
Total Total of all reporting groups

Baseline Measures
   Amiodarone   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   65   130 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   44   39   83 
>=65 years   21   26   47 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (8)   63  (9)   62  (9) 
Gender 
[Units: Participants]
     
Female   31   34   65 
Male   34   31   65 
Region of Enrollment 
[Units: Participants]
     
United States   65   65   130 


  Outcome Measures
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1.  Primary:   Incidence of Atrial Fibrillation Requiring Treatment   [ Time Frame: 7 days ]

2.  Primary:   Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds   [ Time Frame: 7 days ]

3.  Secondary:   Length of Intensive Care Unit Stay   [ Time Frame: Duration of hospitalization ]

4.  Secondary:   Length of Hospital Stay   [ Time Frame: Duration of hospitalization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James E. Tisdale
Organization: Purdue University
phone: 317-613-2315 ext 306
e-mail: jtisdale@iupui.edu


Publications of Results:

Responsible Party: James E. Tisdale, Purdue University
ClinicalTrials.gov Identifier: NCT00127712     History of Changes
Other Study ID Numbers: 0407-16
First Submitted: August 4, 2005
First Posted: August 8, 2005
Results First Submitted: March 2, 2010
Results First Posted: March 24, 2010
Last Update Posted: September 18, 2013