Recruiting

Cardiac Surgery

Sponsor:

Montreal Heart Institute

Code:

NCT04092855

Conditions

Right Ventricular Dysfunction

Right Heart Failure

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04092855

Start date

Dec 10, 2018

Status verified date

Mar, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

112 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Central contacts

Locations

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

More Information

Sponsor

Montreal Heart Institute

Last update posted

Mar 19, 2024

Last verified

Mar, 2024

Keywords

  • Right Ventricular Pressure Waveform

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2024-03-19.