Clinical Trials Directory

Trials / Completed

CompletedNCT03656263

The Clinical Significance of Portal Hypertension After Cardiac Surgery: a Multicenter Prospective Observational Study

The Clinical Significance of Portal Hypertension After Cardiac Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
360 (actual)
Sponsor
Montreal Heart Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

Portal flow pulsatility detected by Doppler ultrasound is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse outcomes based on previous studies performed at the Montreal Heart Institute. This multicenter prospective cohort study aims to determine if portal flow pulsatility after cardiopulmonary bypass separation is associated with a longer requirement of life support after cardiac surgery.

Detailed description

Hypothesis: Portal flow pulsatility detected by Doppler ultrasound during cardiac surgery is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse clinical outcomes. Background: Peri-operative right ventricular failure is associated with a high mortality rate. In this context, organ perfusion is hampered by both the reduction of cardiac output and venous congestion from the elevation of central venous pressure. The clinician's objective is to appreciate the hemodynamic impact on end-organs in an effort to adjust the therapy accordingly since the ultimate goal is to optimize their perfusion. Based on this rationale, organ specific blood flow assessment using Doppler ultrasound could be used to personalize management. In order to non-invasively assess the presence of cardiogenic portal hypertension, Doppler ultrasound can be used to detect portal flow pulsatility, an abnormal variation in the velocity of blood flow within the main portal vein. In two single-center cohort studies, the presence of portal flow pulsatility after cardiac surgery was independently associated with post-operative complications such as major bleeding, acute kidney injury (AKI) and delirium as well as increased length of intensive care unit (ICU) stay. Specific Objectives: This multi-center cohort study aim to determine whether the association between portal flow pulsatility and organ dysfunction seen in previous studies is present across multiple cardiac surgery centers.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTDoppler assessment of portal vein flowDoppler assessment of portal vein flow using peri-operative trans-esophageal echography before and after cardiopulmonary bypass.

Timeline

Start date
2018-11-14
Primary completion
2021-02-20
Completion
2021-02-20
First posted
2018-09-04
Last updated
2021-02-24

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03656263. Inclusion in this directory is not an endorsement.