Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
NCT Number: NCT03656263
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.
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All sexes
Observational
Montreal, Quebec, H1T 1C8, Canada
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.
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Inclusion criteria
Exclusion criteria
Doppler assessment of portal vein flow using peri-operative trans-esophageal echography before and after cardiopulmonary bypass.
Time frame: Up to 28 days
Defined as the time of Persistent Organ Dysfunction (POD) or Death
Time frame: Up to 28 days
Death from any cause
Time frame: Up to 28 days
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
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
Re-operation after the initial surgery for any cause
Time frame: Up to 28 days
Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician.
Time frame: Up to 28 days
Defined as a intensive care delirium screening checklist (ICDSC) score 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
A central neurologic deficit persisting longer than 72 hours
Time frame: Up to 28 days
Number of hours passed in the ICU
Time frame: Up to 28 days
Number of days hospitalized from the day of surgery to discharge
Time frame: Up to 28 days
Number of hours of mechanical ventilation
Time frame: Up to 28 days
Composite endpoint after cardiac proposed by the Society of Thoracic Surgeons
Montreal Heart Institute
Other
The Clinical Significance of Portal Hypertension After Cardiac Surgery
Acronym: TECHNO-MULTI
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