Atrial Fibrillation After Cardiac Surgery-comparing Conventional and Miniaturized Bypass Systems
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Miniaturized bypass system
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiac surgery, Prevention, Conventional bypass system, Miniaturized bypass system, Arrhythmia, The Incidence of atrial fibrillation after cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- Elective CABC patients
Exclusion Criteria:
- Previous episodes of AF of flutter
- Contraindications for betablocker use
- Sick sinus syndrome
- II or III degree atrioventricular block
- Uncontrolled heart failure
- Previous medication of corticosteroids and immunosuppressive medication
- Emergency surgery
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Miniaturized bypass system
Arm Description
Miniaturized bypass system and the incidence of atrial fibrillation after cardiac surgery
Outcomes
Primary Outcome Measures
Atrial fibrillation
The primary endpoint of this study is the incidence of atrial fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT01160393
First Posted
July 5, 2010
Last Updated
October 17, 2017
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT01160393
Brief Title
Atrial Fibrillation After Cardiac Surgery-comparing Conventional and Miniaturized Bypass Systems
Official Title
Atrial Fibrillation After Cardiac Surgery - Prospective, Randomized Study Comparing Conventional and Miniaturized Bypass Systems
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atrial fibrillation (AF) is the most common arrhythmia after cardiac surgery. The incidence of AF varies between 20 - 45 % after (coronary artery bypass grafting) CABG. It may lead to hemodynamic compromise, thromboembolic events, increased length of stay in the hospital and increased morbidity. The underlying cause of AF has been related to a variety of factors. Those most commonly related to the intraoperative management are the use of cardiopulmonary bypass (CPB), the influence of systemic inflammation, myocardial damage, intraoperative fluid management and the need of red blood cell transfusion.
The purpose of the study is to find out the difference in the incidence of atrial fibrillation after CABG when using the conventional (CECC) or mini bypass system (MECC).
The treatment protocol is similar in both groups except the CPB method (CECC vs. MECC). In both methods the investigators use MAQUET tubing and oxygenator. The investigators also collect special blood samples for determining most relevant factors found affecting in the incidence of AF.
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia after cardiac surgery. The incidence of AF varies between 20 - 45 % after (coronary artery bypass grafting) CABG. It may lead to hemodynamic compromise, thromboembolic events, increased length of stay in the hospital and increased morbidity. The underlying cause of AF has been related to a variety of factors. Those most commonly related to the intraoperative management are the use of cardiopulmonary bypass (CPB), the influence of systemic inflammation, myocardial damage, intraoperative fluid management and the need of red blood cell transfusion.
The purpose of the study is to find out the difference in the incidence of atrial fibrillation after CABG when using the conventional (CECC) or mini bypass system (MECC). There has been some evidence in retrospective studies comparing conventional and mini bypass systems that the incidence of AF after mini bypass could be statistically lower.
With the prospective randomized study protocol patient demographic will be similar regarding other variables such as age, gender, previous history of AF, use of beta blockers etc. Only isolated CABG procedures will be included. The amount of patients needed in the study has been calculated so that when the investigators assume that the incidence of AF is normally 45 % and with the mini bypass system the investigators can reduce it to 25 %, the investigators need 330 patients (165 in each group) to show this with the power of 0,8 (a 0,05).
The treatment protocol is similar in both groups except the CPB method (CECC vs. MECC). In both methods the investigators use MAQUET tubing and oxygenator. Fluid management and the use of inotropic agents are standardized and followed by using pulmonary artery catheter. After the operation in the ICU the investigators also use a standardized treatment protocol in the fluid management and in the medication. Patients are ECG-monitored 48 hours after the operation. Possible arrhythmias are documented until the patient is discharged from the hospital.
The investigators also collect special blood samples for determining most relevant factors found affecting in the incidence of AF (IL-6, IL-8, PAI-1).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Cardiac surgery, Prevention, Conventional bypass system, Miniaturized bypass system, Arrhythmia, The Incidence of atrial fibrillation after cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miniaturized bypass system
Arm Type
Other
Arm Description
Miniaturized bypass system and the incidence of atrial fibrillation after cardiac surgery
Intervention Type
Device
Intervention Name(s)
Miniaturized bypass system
Other Intervention Name(s)
Miniaturized extracorporeal circulation
Intervention Description
Compare the conventional bypass system and miniaturized bypass system of the incidence of atrial fibrillation after cardiac surgery
Primary Outcome Measure Information:
Title
Atrial fibrillation
Description
The primary endpoint of this study is the incidence of atrial fibrillation
Time Frame
up to 10 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective CABC patients
Exclusion Criteria:
Previous episodes of AF of flutter
Contraindications for betablocker use
Sick sinus syndrome
II or III degree atrioventricular block
Uncontrolled heart failure
Previous medication of corticosteroids and immunosuppressive medication
Emergency surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pekka Korvenoja, MD
Organizational Affiliation
Cardiac anesthesiologist, KuopioUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
12. IPD Sharing Statement
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Atrial Fibrillation After Cardiac Surgery-comparing Conventional and Miniaturized Bypass Systems
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