Amiodarone prophylaxis for atrial fibrillation in patients undergoing surgery for lung cancer: A controlled, randomized, double blinded trial. - PASCART
Phase 1
- Conditions
- Atrial fibrillation after lung resection due to cancer in the lungMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationMedDRA version: 9.1Level: LLTClassification code 10025065Term: Lung carcinoma cell type unspecified recurrent
- Registration Number
- EUCTR2007-005246-20-DK
- Lead Sponsor
- Aarhus University Hospital, Skejby
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 275
Inclusion Criteria
1) Enlisted for lungresection due to pulmonary neoplasma
2) Elective surgery
3) Willingness of randomisation
4) Above 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) Former pulmonary surgery performed
2) Former heart surgery
3) Resting heart beat below 40 beats/ min
4) AV-blockage of any degree
5) Paroxysmal, persistent or permanent atrial fibrillation or flutter
6) Former insidence of paroxysmal, persistent or permanent atrial fibrillation or flutter
7) Pregnant
8) Breastfeeding
9) Allergy towards the substances in cordarone
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To reduce the incidence of atrial fibrillation after lung resection due to lung cancer;Secondary Objective: To compile the cost-effectiveness of the instituted prophylaxis;Primary end point(s): 1) Atrial fibrillation<br>2) Symptomatic atrial fibrillation<br>3) Length of stay
- Secondary Outcome Measures
Name Time Method