Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery

Not Applicable

Withdrawn

• Conditions: Right Ventricular Ejection Fraction
• Interventions: Procedure: external pacemaker switched off

• Registration Number: NCT04151745
• Lead Sponsor: Medical Centre Leeuwarden

Brief Summary

Temporary pacing with an external pacemaker after open heart surgery - besides preventing arrhythmias and AV-conduction disorders - is used to improve cardiac output. In theory, postoperative stunning temporarily limits stroke volume and SA-node dysfunction compromises an adequate compensatory rise in heartrate to ensure sufficient cardiac output. There is a lack of consensus regarding the use of this form of pacing. Protocols vary widely between hospitals. Moreover, the scientific base for this form of pacing mainly comprises studies dating back to the nineteen sixties and seventies. Major changes in (operating) techniques have taken place since then. Also, the role of the right ventricle in this context has not been studied specifically. The current study aims to investigate the effects of atrial pacing on right ventricular function specifically and hemodynamics in general, in today's postoperative setting. We hypothesize that a reduction in heart rate may lead to decreased right ventricular function.

Detailed Description

When a hemodynamically stable state is achieved, the external pacemaker will be switched off for 30 minutes. Hemodynamic parameters will be acquired directly prior to switching off, 15 respectively 30 minutes after switching off, and 15 minutes after switching back on. To gain insight in the natural course of stunning, this routine will be repeated the next morning. No additional hemodynamic interventions will be allowed in these periods.

Study Timeline

• Study First Submitted: 2019-01-15
• Study Start: 2019-03-15
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age 18 years or older
• admitted to the ICU after onpump open heart surgery
• Swan Ganz thermodilurion catheter in situ

Exclusion Criteria

• participation other trials
• off pump cardiac surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	external pacemaker switched off	When a hemodynamically stable state is achieved, the external pacemaker will be switched off for 30 minutes. Hemodynamic parameters will be acquired directly prior to switching off, 15 respectively 30 minutes after switching off, and 15 minutes after switching back on. To gain insight in the natural course of stunning, this routine will be repeated the next morning.

Primary Outcome Measures

Name	Time	Method
right ventricular ejection fraction	30 minutes after procedure	difference in right ventricular function expressed in RVEF