Atrial Fibrillation After Cardiac Surgery-comparing Conventional and Miniaturized Bypass Systems

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Kuopio University Hospital
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by (Responsible Party):
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01160393
First received: July 5, 2010
Last updated: May 14, 2014
Last verified: May 2014

July 5, 2010
May 14, 2014
July 2010
December 2014   (final data collection date for primary outcome measure)
Atrial fibrillation [ Time Frame: up to 10 days ] [ Designated as safety issue: Yes ]
The primary endpoint of this study is the incidence of atrial fibrillation
Same as current
Complete list of historical versions of study NCT01160393 on ClinicalTrials.gov Archive Site
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Atrial Fibrillation After Cardiac Surgery-comparing Conventional and Miniaturized Bypass Systems
Atrial Fibrillation After Cardiac Surgery - Prospective, Randomized Study Comparing Conventional and Miniaturized Bypass Systems

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).

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Atrial Fibrillation
Procedure: Miniaturized bypass system
Compare the conventional bypass system and miniaturized bypass system of the incidence of atrial fibrillation after cardiac surgery
Other Name: Miniaturized extracorporeal circulation
Miniaturized bypass system
Miniaturized bypass system and the incidence of atrial fibrillation after cardiac surgery
Intervention: Procedure: Miniaturized bypass system
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Pekka Korvenoja, MD +35817 173311 pekka.korvenoja@kuh.fi
Finland
 
NCT01160393
KUH5070216
No
Kuopio University Hospital
Kuopio University Hospital
University of Eastern Finland
Principal Investigator: Pekka Korvenoja, MD Cardiac anesthesiologist, KuopioUH
Kuopio University Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP