Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery

NCT ID: NCT04151745

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2019-12-15

Brief Summary

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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

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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.

Conditions

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Right Ventricular Ejection Fraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To investigate the effects of atrial pacing on right ventricular function and hemodynamics after open heart surgery.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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study group

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.

Group Type OTHER

external pacemaker switched off

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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E.C. Boerma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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E C Boerma, Dr

Role: PRINCIPAL_INVESTIGATOR

Intensive Care

Other Identifiers

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TPO

Identifier Type: -

Identifier Source: org_study_id

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