An observational study in Right Ventricular Dysfunction, Right Heart Failure and Congestive Heart Failure, sponsored by Montreal Heart Institute. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Montreal Heart Institute · Observational
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.
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.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's planned enrollment of 112 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing cardiac surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.
Exclusion Criteria:
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.
Time frame: From thermodilution catheter insertion until 2 hours after ICU arrival
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)
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
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
Time frame: Up to 28 days or until hospital discharge
Incidence of deaths during hospitalisation
Death from any cause
Time frame: 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.
Time frame: 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
Time frame: Up to 28 days or until hospital discharge
Incidence of surgical reintervention for any reasons
Re-operation after the initial surgery for any cause
Time frame: 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
Time frame: 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).
Time frame: Up to 28 days or until hospital discharge
Incidence of stroke
Central neurologic deficit persisting longer than 72 hours
Time frame: Up to 28 days or until hospital discharge
Total duration of ICU stay in hours
Number of hours passed in the ICU
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 28 days or until hospital discharge
Right ventricular ejection fraction
Assessed by the American Society of Echocardiography guidelines
Time frame: 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
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular strain
Assessed by the American Society of Echocardiography guidelines
Time frame: 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
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Right ventricular performance index
Assessed by the American Society of Echocardiography guidelines
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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\]
Time frame: 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)
Time frame: 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
Time frame: From arrival to the operating room until 2 hours after ICU arrival
Plan to share: No
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