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
  Purpose

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).


Condition Intervention
Atrial Fibrillation
Procedure: Miniaturized bypass system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Atrial Fibrillation After Cardiac Surgery - Prospective, Randomized Study Comparing Conventional and Miniaturized Bypass Systems

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 330
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Miniaturized bypass system
Miniaturized bypass system and the incidence of atrial fibrillation after cardiac surgery
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160393

Contacts
Contact: Pekka Korvenoja, MD +35817 173311 pekka.korvenoja@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Pekka Korvenoja, MD    +35817 173311    pekka.korvenoja@kuh.fi   
Sub-Investigator: Sten Ellam, MD         
Sub-Investigator: Otto Pitkänen, MD,PhD         
Sub-Investigator: Esko Tyrväinen, MD         
Sub-Investigator: Jari Halonen, MD         
Sub-Investigator: Antti Valtola, MD         
Sub-Investigator: Vesa Kiviniemi         
Sub-Investigator: Juha Hartikainen, MD, PhD         
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
Investigators
Principal Investigator: Pekka Korvenoja, MD Cardiac anesthesiologist, KuopioUH
  More Information

No publications provided

Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01160393     History of Changes
Other Study ID Numbers: KUH5070216
Study First Received: July 5, 2010
Last Updated: May 14, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:
Atrial fibrillation
Cardiac surgery
Prevention
Conventional bypass system
Miniaturized bypass system
Arrhythmia
The Incidence of atrial fibrillation after cardiac surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014