Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

This study has been completed.
Sponsor:
Collaborator:
Purdue University
Information provided by (Responsible Party):
James E. Tisdale, Purdue University
ClinicalTrials.gov Identifier:
NCT00127712
First received: August 4, 2005
Last updated: September 6, 2013
Last verified: September 2013
Results First Received: March 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
No text entered.

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.
No text entered.

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  
Number of Participants  
[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


  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.


Limitations and Caveats
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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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
Study First Received: August 4, 2005
Results First Received: March 2, 2010
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board