Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery (Outpace)

November 4, 2019 updated by: E.C. Boerma, Medical Centre Leeuwarden
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
right ventricular ejection fraction
Time Frame: 30 minutes after procedure
difference in right ventricular function expressed in RVEF
30 minutes after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Investigators

  • Principal Investigator: E C Boerma, Dr, Intensive care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 15, 2019

Primary Completion (ANTICIPATED)

November 15, 2019

Study Completion (ANTICIPATED)

December 15, 2019

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (ACTUAL)

November 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • TPO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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