Right Ventricular Pressure Waveform Monitoring in Cardiac Surgery (PACEPORT)

March 18, 2024 updated by: Andre Denault, Montreal Heart Institute

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients undergoing cardiac surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From thermodilution catheter insertion until 2 hours after ICU arrival

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
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
Up to 28 days or until hospital discharge
Incidence of deaths during hospitalisation
Time Frame: Up to 30 days or until hospital discharge
Death from any cause
Up to 30 days or until hospital discharge
Incidence of acute kidney injury (AKI)
Time Frame: Up to 28 days or until hospital discharge

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.
Up to 28 days or until hospital discharge
Incidence of major bleeding
Time Frame: Up to 28 days or until hospital discharge

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
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
Re-operation after the initial surgery for any cause
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
Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician
Up to 28 days or until hospital discharge
Incidence of delirium
Time Frame: Up to 28 days or until hospital discharge
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).
Up to 28 days or until hospital discharge
Incidence of stroke
Time Frame: Up to 28 days or until hospital discharge
Central neurologic deficit persisting longer than 72 hours
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
Number of hours passed in the ICU
Up to 28 days or until hospital discharge
Duration of vasopressor requirements (in hours)
Time Frame: Up to 28 days or until hospital discharge
Vasopressors include norepinephrine, epinephrine, dobutamine, vasopressin, phenylephrine, milrinone, isoproterenol and dopamine.
Up to 28 days or until hospital discharge
Duration of hospital stay (in days)
Time Frame: Up to 28 days or until hospital discharge
Number of days hospitalized from the day of surgery to discharge
Up to 28 days or until hospital discharge
Duration of mechanical ventilation (in hours)
Time Frame: Up to 28 days or until hospital discharge
A duration of >24 hours will be considered prolonged ventilation requirements.
Up to 28 days or until hospital discharge
Incidence of major morbidity or mortality
Time Frame: Up to 28 days or until hospital discharge
Including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.
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
Assessed by the American Society of Echocardiography guidelines
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
Assessed by the American Society of Echocardiography guidelines
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
Assessed by the American Society of Echocardiography guidelines
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
Assessed by the American Society of Echocardiography guidelines
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
Assessed by the American Society of Echocardiography guidelines
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
Defined as the difference between the maximal and the minimal velocity during the cardiac cycle divided by the maximal velocity
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
0.0136x Stroke volume index x (Mean pulmonary artery pressure-mean right atrial pressure)
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
The ratio of the mean systemic arterial pressure divided by the mean pulmonary artery pressure
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
Defined as (isovolumic contraction time + isovolumic relaxation time)/RV ejection time
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
Defined as (systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure]
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
Stroke volume divided by the pulmonary artery pulse pressure (systolic minus the diastolic pulmonary artery pressure)
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
Velocity variations of blood flow in the femoral vein during the cardiac cycle
From arrival to the operating room until 2 hours after ICU arrival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Andre Denault, MD,PhD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-2527

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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