Right Ventricular Pressure Waveform Monitoring in Cardiac Surgery

NCT04092855 | Recruiting

• 1 other identifier: 2019-2527
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Ventricular Dysfunction; Right Heart Failure; Congestive Heart Failure

Keywords

Right Ventricular Pressure Waveform

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Up to 28 days or until hospital discharge

• Incidence of deaths during hospitalisation

  Up to 30 days or until hospital discharge

• Incidence of acute kidney injury (AKI)

  Up to 28 days or until hospital discharge

• Incidence of major bleeding

  Up to 28 days or until hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing cardiac surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Ventricular Dysfunction, Right; Heart Failure

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andre Denault, MD,PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Robichaud, RRT

CONTACT

5143763330; sophie.robichaud@icm-mhi.org

Samuel Côté, RRT

CONTACT

5143763330; samuel.cote@icm-mhi.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: September 17, 2019
• Study Start: December 10, 2018
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)