- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151745
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Withdrawn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.
|
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
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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