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

NCT01160393 | Completed

• 1 other identifier: KUH5070216
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Cardiac surgery; Prevention; Conventional bypass system; Miniaturized bypass system; Arrhythmia; The Incidence of atrial fibrillation after cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  The primary endpoint of this study is the incidence of atrial fibrillation

  up to 10 days

Study Arms (1)

Miniaturized bypass system

OTHER

Miniaturized bypass system and the incidence of atrial fibrillation after cardiac surgery

Device: Miniaturized bypass system

Interventions

Miniaturized bypass system DEVICE

Compare the conventional bypass system and miniaturized bypass system of the incidence of atrial fibrillation after cardiac surgery

Also known as: Miniaturized extracorporeal circulation

Miniaturized bypass system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective CABC patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pekka Korvenoja, MD

  Cardiac anesthesiologist, KuopioUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2010
• First Posted: July 12, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

FI (1)