Right Ventricular Ejection FractionOutpaceNCT04151745
Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery
A study testing external pacemaker switched off in people with Right Ventricular Ejection Fraction, run by Frisius Medisch Centrum.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Ejection Fraction
- What is being tested?
- external pacemaker switched off
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- admitted to the ICU after onpump open heart surgery
- Swan Ganz thermodilurion catheter in situ
Who cannot join
- participation other trials
- off pump cardiac surgery
About this study
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.
Read the 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.
- Conditions
- Right Ventricular Ejection Fraction
- Being tested
- external pacemaker switched off
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external pacemaker switched offProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | 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. Receives: Procedure: external pacemaker switched off |
What is being measured
The primary outcome is the main question the study is designed to answer.
right ventricular ejection fraction
difference in right ventricular function expressed in RVEF
Measured: 30 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start15 Mar 2019 (estimated)
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Why it stopped: interaction with another study, not possible to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To investigate the effects of atrial pacing on right ventricular function and hemodynamics after open heart surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.C. Boerma, Frisius Medisch Centrum
- Investigators
- E C Boerma, Dr, Principal investigator, Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151745
- Sponsor's protocol ID
- TPO
- Acronym
- Outpace
- Status last verified
- Nov 2019
- First submitted
- 15 Jan 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04151745
- Acronym / sponsor ID
- Outpace / TPO
- Conditions
- Right Ventricular Ejection Fraction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: interaction with another study, not possible to include patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 15 Mar 2019 (estimated)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To investigate the effects of atrial pacing on right ventricular function and hemodynamics after open heart surgery.
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Procedure: external pacemaker switched offWhen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older
- admitted to the ICU after onpump open heart surgery
- Swan Ganz thermodilurion catheter in situ
Key exclusion criteria (2 listed)
- participation other trials
- off pump cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external pacemaker switched offWhen 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 or surgery | study group |
Primary outcome
right ventricular ejection fraction
Time frame: 30 minutes after procedure
difference in right ventricular function expressed in RVEF
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E C Boerma, Dr principal investigator
Intensive Care
Questions about this trial
What is this clinical trial studying?
A study testing external pacemaker switched off in people with Right Ventricular Ejection Fraction, run by Frisius Medisch Centrum.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right ventricular ejection fraction (time frame: 30 minutes after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.