Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery

Right Ventricular Ejection Fraction Clinical Trial

— Outpace  

Official title:

Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04151745
• Other study ID #: TPO
• Status: Withdrawn
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: November 2019
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Right Ventricular Ejection Fraction

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	right ventricular ejection fraction	difference in right ventricular function expressed in RVEF	30 minutes after procedure