Clinical trial NCT04092855: Right Ventricular Pressure Waveform Monitoring in Cardiac Surgery
Official title: Early Identification and Prediction of Right Ventricular Dysfunction and Failure in Critically Ill Patients: An Observational Non-Interventional Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Ventricular Dysfunction
Right Heart Failure
Congestive Heart Failure
Keywords: Right Ventricular Pressure Waveform
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2019-09-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
timeFrame: From thermodilution catheter insertion until 2 hours after ICU arrival
Secondary outcomes:
measure: Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery
timeFrame: From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours.
measure: Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of deaths during hospitalisation
timeFrame: Up to 30 days or until hospital discharge
measure: Incidence of acute kidney injury (AKI)
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of major bleeding
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of surgical reintervention for any reasons
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of deep sternal wound infection or mediastinitis
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of delirium
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of stroke
timeFrame: Up to 28 days or until hospital discharge
measure: Total duration of ICU stay in hours
timeFrame: Up to 28 days or until hospital discharge
measure: Duration of vasopressor requirements (in hours)
timeFrame: Up to 28 days or until hospital discharge
measure: Duration of hospital stay (in days)
timeFrame: Up to 28 days or until hospital discharge
measure: Duration of mechanical ventilation (in hours)
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of major morbidity or mortality
timeFrame: Up to 28 days or until hospital discharge
measure: Right ventricular ejection fraction
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular fractional area change
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular strain
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Tricuspid annular plane systolic excursion
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular performance index
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Portal flow pulsatility fraction
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular stroke work index
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Relative pulmonary pressure
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular function index
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Pulmonary artery pulsatility index (PAPi)
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Compliance of the pulmonary artery (CPA)
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Pulsatility of femoral venous flow
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Andre Denault, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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