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).

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Miniaturized bypass system

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).

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70211
    • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Miniaturized bypass system; Miniaturized bypass system and the incidence of atrial fibrillation after cardiac surgery	Device: Miniaturized bypass system; Compare the conventional bypass system and miniaturized bypass system of the incidence of atrial fibrillation after cardiac surgery; Other Names: Miniaturized extracorporeal circulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	The primary endpoint of this study is the incidence of atrial fibrillation	up to 10 days

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: University of Eastern Finland
• Investigators: Principal Investigator: Pekka Korvenoja, MD, Cardiac anesthesiologist, KuopioUH

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 5, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (Estimate): July 12, 2010

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Arrhythmia; Prevention; Cardiac surgery; Conventional bypass system; Miniaturized bypass system; The Incidence of atrial fibrillation after cardiac surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: KUH5070216