An observational study in Surgery--Complications, Congestive Heart Failure and Right Heart Failure, sponsored by Montreal Heart Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Montreal Heart Institute · Observational
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.
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.
332 studies on the registry are indexed under Hypertension, Portal; 106 are open to participants now.
This study's enrollment of 360 is above the median of 152 across 119 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing cardiac surgery at high risk for complications.
High surgical risk defined as at least one of the following:
Exclusion Criteria:
Defined as either: * Multiple surgical procedures planned and/or, * EuroSCORE ≥ 5% and/or, * Known pulmonary hypertension (mPAP\>25 mmHg or sPAP \> 40 mmHg)
Diagnostic Test: Doppler assessment of portal vein flow
Doppler assessment of portal vein flow using peri-operative trans-esophageal echography before and after cardiopulmonary bypass.
Duration of invasive life support after cardiac surgery. (Tpod)
Defined as the time of Persistent Organ Dysfunction (POD) or Death
Time frame: Up to 28 days
All cause death
Death from any cause
Time frame: Up to 28 days
Acute kidney injury 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.
Time frame: Up to 28 days
Major bleeding defined by the Bleeding Academic Research Consortium (BARC)
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
Surgical reintervention for any reasons
Re-operation after the initial surgery for any cause
Time frame: Up to 28 days
Deep sternal wound infection or mediastinitis
Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician.
Time frame: Up to 28 days
Delirium
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
Stroke
A central neurologic deficit persisting longer than 72 hours
Time frame: Up to 28 days
Total duration of ICU stay in hours
Number of hours passed in the ICU
Time frame: Up to 28 days
Duration of hospital stay (in days)
Number of days hospitalized from the day of surgery to discharge
Time frame: Up to 28 days
Duration of mechanical ventilation (in hours)
Number of hours of mechanical ventilation
Time frame: Up to 28 days
A composite outcome of major morbidity or mortality (41): including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.
Composite endpoint after cardiac proposed by the Society of Thoracic Surgeons
Time frame: Up to 28 days
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Montreal Heart Institute