Right Ventricular DysfunctionPACEPORTNCT04092855
Right Ventricular Pressure Waveform Monitoring in Cardiac Surgery
An observational study of Right Ventricular Dysfunction and Right Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction, Right Heart Failure, Congestive Heart Failure
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2018to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Adult patients undergoing cardiac surgery.
Who may be able to join
- -Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.
Who cannot join
- Emergency surgery or inability to obtain consent
- Concomitant diseases such as pericardial constriction, congenital heart disease, severe valvular regurgitation, right ventricular systolic dysfunction, or right ventricular infarction.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Sophie Robichaud, RRT, 5143763330 ext. 3305, sophie.robichaud@icm-mhi.org
Samuel Cote, RRT, 5143763330 ext. 4262, samuel.cote@icm-mhi.org
About this study
Official title: Early Identification and Prediction of Right Ventricular Dysfunction and Failure in Critically Ill Patients: An Observational Non-Interventional Cohort Study
RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes.
However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. The investigator's primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.
Read the detailed description
Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload. RV dysfunction can occur in a number of clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery.
Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described: RV fractional area change (RVFAC) < 35 %, tricuspid annular plane systolic excursion (TAPSE) < 16 mm, tissue Doppler S wave velocity <10 cm/s, RV ejection fraction (RVEF) <45% and RV dilation. However, echocardiographic indices alone are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognised as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation. RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system. The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension. It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.
- Keywords
- Right Ventricular Pressure Waveform
- Medical subject headings
- Ventricular Dysfunction, Right, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure > 4 mmHg.
Measured: From thermodilution catheter insertion until 2 hours after ICU arrival
Secondary outcomes (26)
Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery
Difficult separation from cardiopulmonary bypass: instability requiring at least two different types of pharmacological agents (i.e., inotropes ± vasopressors ± inhaled agents) Complex separation from cardiopulmonary bypass: Hemodynamic instability requiring return on cardiopulmonary bypass or addition of mechanical support (intra-aortic balloon pump or extra-corporeal membrane oxygenator)
Measured: From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours.
Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery
TPOD is a continuous variable representative of the burden of care and morbidity during the first 28 days following cardiac surgery and was chosen to circumvent issues arising for using other clinical endpoint such as ICU length of stay
Measured: Up to 28 days or until hospital discharge
Incidence of deaths during hospitalisation
Death from any cause
Measured: Up to 30 days or until hospital discharge
Incidence of acute kidney injury (AKI)
Acute kidney injury (AKI) according to KDIGO serum creatinine criteria:
Stage 1: ≥50% or 27 umol/L increases in serum creatinine, Stage 2: ≥100% increase in serum creatinine, Stage 3 ≥200% increase in serum creatinine or an increase to a level of ≥254 umol/L or dialysis initiation.
Measured: Up to 28 days or until hospital discharge
Incidence of major bleeding
Major bleeding is defined by the Bleeding Academic Research Consortium (BARC) as one of the following:
- Perioperative intracranial bleeding within 48h
- Reoperation after closure of sternotomy for the purpose of controlling bleeding
- Transfusion of ≥5 units of whole blood of packed red blood cells within a 48 hours period
- Chest tube output ≥2L within a 24 hours period
Measured: Up to 28 days or until hospital discharge
Incidence of surgical reintervention for any reasons
Re-operation after the initial surgery for any cause
Measured: Up to 28 days or until hospital discharge
Incidence of deep sternal wound infection or mediastinitis
Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician
Measured: Up to 28 days or until hospital discharge
Incidence of delirium
Delirium is defined as an intensive care delirium screening checklist (ICDSC) score(18) of ≥4 in the week following surgery or positive result for the Confusion Assessment Method for the ICU (CAM-ICU).
Measured: Up to 28 days or until hospital discharge
Incidence of stroke
Central neurologic deficit persisting longer than 72 hours
Measured: Up to 28 days or until hospital discharge
Total duration of ICU stay in hours
Number of hours passed in the ICU
Measured: Up to 28 days or until hospital discharge
Duration of vasopressor requirements (in hours)
Vasopressors include norepinephrine, epinephrine, dobutamine, vasopressin, phenylephrine, milrinone, isoproterenol and dopamine.
Measured: Up to 28 days or until hospital discharge
Duration of hospital stay (in days)
Number of days hospitalized from the day of surgery to discharge
Measured: Up to 28 days or until hospital discharge
Duration of mechanical ventilation (in hours)
A duration of >24 hours will be considered prolonged ventilation requirements.
Measured: Up to 28 days or until hospital discharge
Incidence of major morbidity or mortality
Including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.
Measured: Up to 28 days or until hospital discharge
Right ventricular ejection fraction
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular fractional area change
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular strain
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Tricuspid annular plane systolic excursion
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular performance index
Assessed by the American Society of Echocardiography guidelines
Measured: From arrival to the operating room until 2 hours after ICU arrival
Portal flow pulsatility fraction
Defined as the difference between the maximal and the minimal velocity during the cardiac cycle divided by the maximal velocity
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular stroke work index
0.0136x Stroke volume index x (Mean pulmonary artery pressure-mean right atrial pressure)
Measured: From arrival to the operating room until 2 hours after ICU arrival
Relative pulmonary pressure
The ratio of the mean systemic arterial pressure divided by the mean pulmonary artery pressure
Measured: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular function index
Defined as (isovolumic contraction time + isovolumic relaxation time)/RV ejection time
Measured: From arrival to the operating room until 2 hours after ICU arrival
Pulmonary artery pulsatility index (PAPi)
Defined as (systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure]
Measured: From arrival to the operating room until 2 hours after ICU arrival
Compliance of the pulmonary artery (CPA)
Stroke volume divided by the pulmonary artery pulse pressure (systolic minus the diastolic pulmonary artery pressure)
Measured: From arrival to the operating room until 2 hours after ICU arrival
Pulsatility of femoral venous flow
Velocity variations of blood flow in the femoral vein during the cardiac cycle
Measured: From arrival to the operating room until 2 hours after ICU arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start10 Dec 2018
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Andre Denault, Montreal Heart Institute
- Investigators
- Andre Denault, MD,PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092855
- Sponsor's protocol ID
- 2019-2527
- Acronym
- PACEPORT
- Status last verified
- Mar 2024
- First submitted
- 25 Apr 2019
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.
PubMed 18378625Denault AY, Bussières J, Carrier M, Mathieu P, and the DSBSG. The importance of difficult separation from cardiopulmonary bypass: the Montreal and Quebec Heart Institute experience. Exp Clin Cardiol. 2006;11 (1):37.
Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
PubMed 27470232Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859Raymond M, Gronlykke L, Couture EJ, Desjardins G, Cogan J, Cloutier J, Lamarche Y, L'Allier PL, Ravn HB, Couture P, Deschamps A, Chamberland ME, Ayoub C, Lebon JS, Julien M, Taillefer J, Rochon A, Denault AY. Perioperative Right Ventricular Pressure Monitoring in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1090-1104. doi: 10.1053/j.jvca.2018.08.198. Epub 2018 Aug 25.
PubMed 30269893Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623.
PubMed 19151264Naeije R, Manes A. The right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2014 Dec;23(134):476-87. doi: 10.1183/09059180.00007414.
PubMed 25445946Denault AY, Chaput M, Couture P, Hebert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. doi: 10.1016/j.jtcvs.2006.03.014.
PubMed 16798301Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5.
PubMed 25432139St-Pierre P, Deschamps A, Cartier R, Basmadjian AJ, Denault AY. Inhaled milrinone and epoprostenol in a patient with severe pulmonary hypertension, right ventricular failure, and reduced baseline brain saturation value from a left atrial myxoma. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):723-9. doi: 10.1053/j.jvca.2012.10.017. Epub 2013 Apr 26. No abstract available.
PubMed 23623891Amsallem M, Kuznetsova T, Hanneman K, Denault A, Haddad F. Right heart imaging in patients with heart failure: a tale of two ventricles. Curr Opin Cardiol. 2016 Sep;31(5):469-82. doi: 10.1097/HCO.0000000000000315.
PubMed 27467173Korshin A, Gronlykke L, Nilsson JC, Moller-Sorensen H, Ihlemann N, Kjoller M, Damgaard S, Lehnert P, Hassager C, Kjaergaard J, Ravn HB. The feasibility of tricuspid annular plane systolic excursion performed by transesophageal echocardiography throughout heart surgery and its interchangeability with transthoracic echocardiography. Int J Cardiovasc Imaging. 2018 Jul;34(7):1017-1028. doi: 10.1007/s10554-018-1306-4. Epub 2018 Jan 30.
PubMed 29383465Hrymak C, Strumpher J, Jacobsohn E. Acute Right Ventricle Failure in the Intensive Care Unit: Assessment and Management. Can J Cardiol. 2017 Jan;33(1):61-71. doi: 10.1016/j.cjca.2016.10.030. Epub 2016 Nov 11.
PubMed 28024557Stoppe C, McDonald B, Benstoem C, Elke G, Meybohm P, Whitlock R, Fremes S, Fowler R, Lamarche Y, Jiang X, Day AG, Heyland DK. Evaluation of Persistent Organ Dysfunction Plus Death As a Novel Composite Outcome in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):30-8. doi: 10.1053/j.jvca.2015.07.035. Epub 2015 Jul 29.
PubMed 26847748Rubenfeld GD, Angus DC, Pinsky MR, Curtis JR, Connors AF Jr, Bernard GR. Outcomes research in critical care: results of the American Thoracic Society Critical Care Assembly Workshop on Outcomes Research. The Members of the Outcomes Research Workshop. Am J Respir Crit Care Med. 1999 Jul;160(1):358-67. doi: 10.1164/ajrccm.160.1.9807118. No abstract available.
PubMed 10390426
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Prediction of Right Ventricular Dysfunction and Failure in Critically Ill Patients: An Observational Non-Interventional Cohort Study
- ClinicalTrials.gov ID
- NCT04092855
- Acronym / sponsor ID
- PACEPORT / 2019-2527
- Keywords
- Right Ventricular Pressure Waveform
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Sep 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.
RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes.
However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. The investigator's primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.
Detailed description
Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload. RV dysfunction can occur in a number of clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery.
Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described: RV fractional area change (RVFAC) < 35 %, tricuspid annular plane systolic excursion (TAPSE) < 16 mm, tissue Doppler S wave velocity <10 cm/s, RV ejection fraction (RVEF) <45% and RV dilation. However, echocardiographic indices alone are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognised as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation. RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system. The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension. It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery.
Key inclusion criteria (1 listed)
- -Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.
Key exclusion criteria (2 listed)
- Emergency surgery or inability to obtain consent
- Concomitant diseases such as pericardial constriction, congenital heart disease, severe valvular regurgitation, right ventricular systolic dysfunction, or right ventricular infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
Time frame: From thermodilution catheter insertion until 2 hours after ICU arrival
Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure > 4 mmHg.
26 secondary outcomes
Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery
Time frame: From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours.
Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery
Time frame: Up to 28 days or until hospital discharge
Incidence of deaths during hospitalisation
Time frame: Up to 30 days or until hospital discharge
Incidence of acute kidney injury (AKI)
Time frame: Up to 28 days or until hospital discharge
Incidence of major bleeding
Time frame: Up to 28 days or until hospital discharge
Incidence of surgical reintervention for any reasons
Time frame: Up to 28 days or until hospital discharge
Incidence of deep sternal wound infection or mediastinitis
Time frame: Up to 28 days or until hospital discharge
Incidence of delirium
Time frame: Up to 28 days or until hospital discharge
Incidence of stroke
Time frame: Up to 28 days or until hospital discharge
Total duration of ICU stay in hours
Time frame: Up to 28 days or until hospital discharge
Duration of vasopressor requirements (in hours)
Time frame: Up to 28 days or until hospital discharge
Duration of hospital stay (in days)
Time frame: Up to 28 days or until hospital discharge
Duration of mechanical ventilation (in hours)
Time frame: Up to 28 days or until hospital discharge
Incidence of major morbidity or mortality
Time frame: Up to 28 days or until hospital discharge
Right ventricular ejection fraction
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular fractional area change
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular strain
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Tricuspid annular plane systolic excursion
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular performance index
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Portal flow pulsatility fraction
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular stroke work index
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Relative pulmonary pressure
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular function index
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Pulmonary artery pulsatility index (PAPi)
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Compliance of the pulmonary artery (CPA)
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Pulsatility of femoral venous flow
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 18378625Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.
- BackgroundDenault AY, Bussières J, Carrier M, Mathieu P, and the DSBSG. The importance of difficult separation from cardiopulmonary bypass: the Montreal and Quebec Heart Institute experience. Exp Clin Cardiol. 2006;11 (1):37.
- Background: PubMed 27470232Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
- Background: PubMed 20620859Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
- Background: PubMed 30269893Raymond M, Gronlykke L, Couture EJ, Desjardins G, Cogan J, Cloutier J, Lamarche Y, L'Allier PL, Ravn HB, Couture P, Deschamps A, Chamberland ME, Ayoub C, Lebon JS, Julien M, Taillefer J, Rochon A, Denault AY. Perioperative Right Ventricular Pressure Monitoring in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1090-1104. doi: 10.1053/j.jvca.2018.08.198. Epub 2018 Aug 25.
- Background: PubMed 19151264Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623.
- Background: PubMed 25445946Naeije R, Manes A. The right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2014 Dec;23(134):476-87. doi: 10.1183/09059180.00007414.
- Background: PubMed 16798301Denault AY, Chaput M, Couture P, Hebert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. doi: 10.1016/j.jtcvs.2006.03.014.
- Background: PubMed 25432139Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5.
- Background: PubMed 23623891St-Pierre P, Deschamps A, Cartier R, Basmadjian AJ, Denault AY. Inhaled milrinone and epoprostenol in a patient with severe pulmonary hypertension, right ventricular failure, and reduced baseline brain saturation value from a left atrial myxoma. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):723-9. doi: 10.1053/j.jvca.2012.10.017. Epub 2013 Apr 26. No abstract available.
- Background: PubMed 27467173Amsallem M, Kuznetsova T, Hanneman K, Denault A, Haddad F. Right heart imaging in patients with heart failure: a tale of two ventricles. Curr Opin Cardiol. 2016 Sep;31(5):469-82. doi: 10.1097/HCO.0000000000000315.
- Background: PubMed 29383465Korshin A, Gronlykke L, Nilsson JC, Moller-Sorensen H, Ihlemann N, Kjoller M, Damgaard S, Lehnert P, Hassager C, Kjaergaard J, Ravn HB. The feasibility of tricuspid annular plane systolic excursion performed by transesophageal echocardiography throughout heart surgery and its interchangeability with transthoracic echocardiography. Int J Cardiovasc Imaging. 2018 Jul;34(7):1017-1028. doi: 10.1007/s10554-018-1306-4. Epub 2018 Jan 30.
- 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.
Andre Denault, MD,PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction and Right Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Robichaud, RRT (5143763330 ext. 3305, sophie.robichaud@icm-mhi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU (time frame: From thermodilution catheter insertion until 2 hours after ICU arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092855, which also lists 27 linked publications.
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 19 Mar 2024.