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Clinical Trials/NCT04151745
NCT04151745
Withdrawn
Not Applicable

Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery

Medical Centre Leeuwarden0 sitesMarch 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Right Ventricular Ejection Fraction
Sponsor
Medical Centre Leeuwarden
Primary Endpoint
right ventricular ejection fraction
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2019
End Date
December 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Medical Centre Leeuwarden
Responsible Party
Principal Investigator
Principal Investigator

E.C. Boerma

Principal Investigator

Medical Centre Leeuwarden

Eligibility Criteria

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

Outcomes

Primary Outcomes

right ventricular ejection fraction

Time Frame: 30 minutes after procedure

difference in right ventricular function expressed in RVEF

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