Right Ventricular DysfunctionReVERSENCT03301571
Right Ventricular Echocardiography in caRdiac SurgEry
A study testing Change in preload and afterload, Inspired oxygen and Pacemaker mode in people with Right Ventricular Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac failure after cardiac surgery substantially. A comprehensive understanding of this condition is paramount in order to achieve success in treatment and early diagnosis. This study has two main aims. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- Change in preload and afterload, Inspired oxygen and Pacemaker mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 4 May 2017to 5 Oct 2017
- 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
- Elective coronary artery bypass graft patients
- Normal left ventricular function defined as LVEF over 50 % on TTE preoperatively
Who cannot join
- Pre-existing right ventricular malformations
- Severe right ventricular impairment preoperatively
- Pre-existing non-sinus rhythm
- Pre-existing mitral valve stenosis or severe regurgitation
- Pre-existing pulmonary hypertension
- Pre-existing tricuspid valve stenosis or severe regurgitation
- Patients with contraindication to TEE probe placement such as oesophageal stricture or obstruction
- Patients with contraindication to Swan-Ganz catheter placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery
Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac failure after cardiac surgery substantially. A comprehensive understanding of this condition is paramount in order to achieve success in treatment and early diagnosis.
This study has two main aims.
Perioperative aim:
To investigate correlations between changes in echocardiographic measurements and hemodynamic changes at baseline and following coronary artery bypass graft (CABG) surgery.
Postoperative aim:
To evaluate changes in haemodynamics and echocardiographic parameters during separate physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes (AAI/DDD/VVI)).
Read the detailed description
Clinical procedure:
For the operation standard procedures for anaesthesia, surgery and cardiopulmonary bypass will be used. This includes installment of a pulmonary artery catheter and performing a transesophageal echocardiography. For the purpose of this study additional TEE images and a transthoracic echocardiography (TTE) will be obtained in order to correlate different echocardiographic indices with haemodynamic measurements and investigate any differences between TTE and TEE measurements.
Transthoracic echocardiography (TTE):
Basic TTE will be performed after anaesthesia induction, before surgery commences and repeated immediately after arrival at the ICU.
Image acquisitions from TTE:
- 2D apical 4-chamber view for right ventricular fractional area change (RVFAC)
- M-mode tricuspid annular plane systolic excursion (TAPSE).
- M-mode lateral mitral annular plane systolic excursion (MAPSE) measurements
Transoesophageal echocardiography (TEE):
After probe placement and before commencing surgery a TEE will be performed. The probe will be left in place during surgery for continuous imaging. Standard views used for patient treatment will be acquired in accordance with the requirements of the treating anaesthesiologist and surgeon.
Additional views will be added in order to obtain standard 2D measures, M-mode measures, spectral doppler measures, myocardial doppler tissue imaging, strain and 3D measures of RV function.
Measurements will be performed at different stages throughout surgery following a period of relative hemodynamic stability defined as: 1 minute of no more than 10 beats/min variation in heart rate, maximum variation of 10 mmHg in mean arterial pressure, maximum variation of 3 mmHg in central venous pressure and no change in administration of vasoactive drugs. If hemodynamic stability cannot be achieved an annotation comment will be entered.
Time points for echocardiography:
TEE will be performed at four different time points during and immediately after surgery:
Stage 1: After induction of anaesthesia. Stage 2: After full sternotomy Stage 3: After completion of cardiopulmonary bypass Stage 4: Immediately after arrival at the ICU and will be repeated after each intervention
Interventions Each intervention will be investigated separately and before each intervention the patient will return to hemodynamic baseline.
Trendelenburg position for 5 minutes will be investigated. Following positive end-expiratory pressures will be investigated: 0 cm H2O, 5 cm H2O and 10 cm H2O.
Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes at each setting.
Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm
- Conditions
- Right Ventricular Dysfunction
- Being tested
- Change in preload and afterload, Inspired oxygen, Pacemaker mode
- Keywords
- Coronary artery bypass graft, Echocardiography
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in preload and afterloadOther
Afterload: Three levels of positive end-expiratory pressure (PEEP) will be examined post-operatively: 0 cm H20, 5 cm H2O, 10 cm H2O Preload: Trendelenburg position for 5 minutes will be investigated
Inspired oxygenOther
Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively
Pacemaker modeOther
Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All patients will receive the treatment (CABG) and postoperatively three different interventions:
1. Change in preload and afterload
2. Change in inspired oxygen
3. Change in pacemaker modes Receives: Other: Change in preload and afterload; Other: Inspired oxygen; Other: Pacemaker mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in right ventricular function during CABG assessed with TAPSE
Assessing the change in RV function during CABG surgery
Measured: During a standard CABG operation
Secondary outcomes (26)
Right ventricular function assessed with TAPSE after each intervention
Change in TAPSE after each intervention
Measured: Immediate postoperative period
Change in cardiac output measured with Swan-Ganz during CABG
Cardiac output measured with the thermodilution technique
Measured: During a standard CABG operation
Change in cardiac output measured with Swan-Ganz after each intervention
Cardiac output measured with the thermodilution technique
Measured: Immediate postoperative period
Response in right ventricular function parameter S' to each intervention
Change in S'
Measured: Immediate postoperative period
Response in right ventricular function parameter S' during CABG
Change in S'
Measured: During a standard CABG operation
Response in right ventricular function parameter Tei index to each intervention
Change in Tei index
Measured: Immediate postoperative period
Response in right ventricular function parameter Tei index during a standard CABG operation
Change in Tei index
Measured: During a standard CABG operation
Response in right ventricular function parameter RVFAC to each intervention
Change in RVFAC
Measured: Immediate postoperative period
Response in right ventricular function parameter RVFAC during a standard CABG operation
Change in RVFAC
Measured: During a standard CABG operation
Response in left ventricular function parameter MAPSE to each intervention
Change in MAPSE
Measured: Immediate postoperative period
Response in left ventricular function parameter MAPSE during a standard CABG operation
Change in MAPSE
Measured: During a standard CABG operation
Response in right ventricular function parameter strain % to each intervention
Change in strain %
Measured: Immediate postoperative period
Response in right ventricular function parameter strain % during a standard CABG operation
Change in strain %
Measured: During a standard CABG operation
Response in right ventricular function parameter strain rate to each intervention
Change in strain rate
Measured: Immediate postoperative period
Response in right ventricular function parameter strain rate during a standard CABG operation
Change in strain rate
Measured: During a standard CABG operation
Response in right ventricular function parameter RV size to each intervention
Change in RV size
Measured: Immediate postoperative period
Response in right ventricular function parameter RV size during a standard CABG operation
Change in RV size
Measured: During a standard CABG operation
Response in right ventricular function parameter pulmonary artery flow velocity to each intervention
Change in flow velocity in pulmonary artery
Measured: Immediate postoperative period
Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation
Change in flow velocity in pulmonary artery
Measured: During a standard CABG operation
Response in right ventricular function parameter RVEF to each intervention
Change in RVEF measured with 3D echo
Measured: Immediate postoperative period
Response in right ventricular function parameter RVEF during a standard CABG operation
Change in RVEF measured with 3D echo
Measured: During a standard CABG operation
Response in right ventricular function parameter RVEF during CABG
Change in RVEF measured with 3D echo
Measured: Immediate postoperative period
Change in cardiac output measured with Swan Ganz in response during a standard CABG operation
Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.
Measured: During a standard CABG operation
Change in cardiac output measured with Swan Ganz in response to each intervention
Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.
Measured: Immediate postoperative period
Change in hemodynamic pressures in response to each intervention
Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter
Measured: Immediate postoperative period
Change in hemodynamic pressures during a standard CABG operation
Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter
Measured: During a standard CABG operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start4 May 2017
- Primary completion5 Oct 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive the same interventions
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Grønlykke, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Grønlykke, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301571
- Sponsor's protocol ID
- 17005565
- Acronym
- ReVERSE
- Status last verified
- Jan 2018
- First submitted
- 19 Sep 2017
- Last updated
- 9 Jan 2018
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT03301571
- Acronym / sponsor ID
- ReVERSE / 17005565
- Conditions
- Right Ventricular Dysfunction
- Keywords
- Coronary artery bypass graft, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 4 Oct 2017 (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.
Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac failure after cardiac surgery substantially. A comprehensive understanding of this condition is paramount in order to achieve success in treatment and early diagnosis.
This study has two main aims.
Perioperative aim:
To investigate correlations between changes in echocardiographic measurements and hemodynamic changes at baseline and following coronary artery bypass graft (CABG) surgery.
Postoperative aim:
To evaluate changes in haemodynamics and echocardiographic parameters during separate physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes (AAI/DDD/VVI)).
Detailed description
Clinical procedure:
For the operation standard procedures for anaesthesia, surgery and cardiopulmonary bypass will be used. This includes installment of a pulmonary artery catheter and performing a transesophageal echocardiography. For the purpose of this study additional TEE images and a transthoracic echocardiography (TTE) will be obtained in order to correlate different echocardiographic indices with haemodynamic measurements and investigate any differences between TTE and TEE measurements.
Transthoracic echocardiography (TTE):
Basic TTE will be performed after anaesthesia induction, before surgery commences and repeated immediately after arrival at the ICU.
Image acquisitions from TTE:
- 2D apical 4-chamber view for right ventricular fractional area change (RVFAC)
- M-mode tricuspid annular plane systolic excursion (TAPSE).
- M-mode lateral mitral annular plane systolic excursion (MAPSE) measurements
Transoesophageal echocardiography (TEE):
After probe placement and before commencing surgery a TEE will be performed. The probe will be left in place during surgery for continuous imaging. Standard views used for patient treatment will be acquired in accordance with the requirements of the treating anaesthesiologist and surgeon.
Additional views will be added in order to obtain standard 2D measures, M-mode measures, spectral doppler measures, myocardial doppler tissue imaging, strain and 3D measures of RV function.
Measurements will be performed at different stages throughout surgery following a period of relative hemodynamic stability defined as: 1 minute of no more than 10 beats/min variation in heart rate, maximum variation of 10 mmHg in mean arterial pressure, maximum variation of 3 mmHg in central venous pressure and no change in administration of vasoactive drugs. If hemodynamic stability cannot be achieved an annotation comment will be entered.
Time points for echocardiography:
TEE will be performed at four different time points during and immediately after surgery:
Stage 1: After induction of anaesthesia. Stage 2: After full sternotomy Stage 3: After completion of cardiopulmonary bypass Stage 4: Immediately after arrival at the ICU and will be repeated after each intervention
Interventions Each intervention will be investigated separately and before each intervention the patient will return to hemodynamic baseline.
Trendelenburg position for 5 minutes will be investigated. Following positive end-expiratory pressures will be investigated: 0 cm H2O, 5 cm H2O and 10 cm H2O.
Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes at each setting.
Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive the same interventions
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Other: Change in preload and afterload, Other: Inspired oxygen, Other: Pacemaker modeAll patients will receive the treatment (CABG) and postoperatively three different interventions: 1. Change in preload and afterload 2. Change in inspired oxygen 3. Change in pacemaker modes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective coronary artery bypass graft patients
- Normal left ventricular function defined as LVEF over 50 % on TTE preoperatively
Key exclusion criteria (8 listed)
- Pre-existing right ventricular malformations
- Severe right ventricular impairment preoperatively
- Pre-existing non-sinus rhythm
- Pre-existing mitral valve stenosis or severe regurgitation
- Pre-existing pulmonary hypertension
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 |
|---|---|---|
| Change in preload and afterloadAfterload: Three levels of positive end-expiratory pressure (PEEP) will be examined post-operatively: 0 cm H20, 5 cm H2O, 10 cm H2O Preload: Trendelenburg position for 5 minutes will be investigated | Other | All patients |
| Inspired oxygenFollowing fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively | Other | All patients |
| Pacemaker modeFollowing pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm | Other | All patients |
Primary outcome
Change in right ventricular function during CABG assessed with TAPSE
Time frame: During a standard CABG operation
Assessing the change in RV function during CABG surgery
26 secondary outcomes
Right ventricular function assessed with TAPSE after each intervention
Time frame: Immediate postoperative period
Change in cardiac output measured with Swan-Ganz during CABG
Time frame: During a standard CABG operation
Change in cardiac output measured with Swan-Ganz after each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter S' to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter S' during CABG
Time frame: During a standard CABG operation
Response in right ventricular function parameter Tei index to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter Tei index during a standard CABG operation
Time frame: During a standard CABG operation
Response in right ventricular function parameter RVFAC to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter RVFAC during a standard CABG operation
Time frame: During a standard CABG operation
Response in left ventricular function parameter MAPSE to each intervention
Time frame: Immediate postoperative period
Response in left ventricular function parameter MAPSE during a standard CABG operation
Time frame: During a standard CABG operation
Response in right ventricular function parameter strain % to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter strain % during a standard CABG operation
Time frame: During a standard CABG operation
Response in right ventricular function parameter strain rate to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter strain rate during a standard CABG operation
Time frame: During a standard CABG operation
Response in right ventricular function parameter RV size to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter RV size during a standard CABG operation
Time frame: During a standard CABG operation
Response in right ventricular function parameter pulmonary artery flow velocity to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation
Time frame: During a standard CABG operation
Response in right ventricular function parameter RVEF to each intervention
Time frame: Immediate postoperative period
Response in right ventricular function parameter RVEF during a standard CABG operation
Time frame: During a standard CABG operation
Response in right ventricular function parameter RVEF during CABG
Time frame: Immediate postoperative period
Change in cardiac output measured with Swan Ganz in response during a standard CABG operation
Time frame: During a standard CABG operation
Change in cardiac output measured with Swan Ganz in response to each intervention
Time frame: Immediate postoperative period
Change in hemodynamic pressures in response to each intervention
Time frame: Immediate postoperative period
Change in hemodynamic pressures during a standard CABG operation
Time frame: During a standard CABG operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Right Ventricular Dysfunction
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
RecruitingPhase 2
Feasibility Trial for a Right Ventricular Failure Platform Trial
Pulmonary Hypertension, Right Ventricular Dysfunction
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
Recruiting
Comparison of Milrinone and Epinephrine on TAPSE
Cardiac Anaesthesia, Cardiopulmonary Bypass
Not yet recruitingObservational study
Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
Right Ventricular Dysfunction, Cardiopulmonary Diseases
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.
Lars Grønlykke, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change in preload and afterload, Inspired oxygen and Pacemaker mode in people with Right Ventricular Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in right ventricular function during CABG assessed with TAPSE (time frame: During a standard CABG operation). 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 9 Jan 2018.