Clinical trial NCT03656263: The Clinical Significance of Portal Hypertension After Cardiac Surgery: a Multicenter Prospective Observational Study
Official title: The Clinical Significance of Portal Hypertension After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Congestive Heart Failure
Right Heart Failure
Anesthesia
Venous Congestion
Keywords: echocardiography
Portal Doppler
Cardiac surgery
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery at high risk for complications.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years old) and able to give informed consent undergoing cardiac surgery with the use of CPB for whom peri-operative TEE is planned.
* High surgical risk defined as at least one of the following:

  1. Multiple surgical procedures planned
  2. EuroSCORE II ≥ 5%
  3. Known pulmonary hypertension (mPAP\>25mmHg or sPAP\>40mmHg).

Exclusion Criteria:

* Patient with a critical pre-operative state defined as vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation or cardiac arrest necessitating resuscitation.
* Patient with known condition that could interfere with portal flow assessment or interpretation (liver cirrhosis, portal vein thrombosis)
* Planned cardiac transplantation
* Planned ventricular assist device implantation

Primary outcomes:
measure: Duration of invasive life support after cardiac surgery. (Tpod)
timeFrame: Up to 28 days
Secondary outcomes:
measure: All cause death
timeFrame: Up to 28 days
measure: Acute kidney injury according to KDIGO serum creatinine criteria
timeFrame: Up to 28 days
measure: Major bleeding defined by the Bleeding Academic Research Consortium (BARC)
timeFrame: Up to 28 days
measure: Surgical reintervention for any reasons
timeFrame: Up to 28 days
measure: Deep sternal wound infection or mediastinitis
timeFrame: Up to 28 days
measure: Delirium
timeFrame: Up to 28 days
measure: Stroke
timeFrame: Up to 28 days
measure: Total duration of ICU stay in hours
timeFrame: Up to 28 days
measure: Duration of hospital stay (in days)
timeFrame: Up to 28 days
measure: Duration of mechanical ventilation (in hours)
timeFrame: Up to 28 days
measure: 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.
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: André Denault, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Denault A, Couture EJ, De Medicis E, Shim JK, Mazzeffi M, Henderson RA, Langevin S, Dhawan R, Michaud M, Guensch DP, Berger D, Erb JM, Gebhard CE, Royse C, Levy D, Lamarche Y, Dagenais F, Deschamps A, Desjardins G, Beaubien-Souligny W. Perioperative Doppler ultrasound assessment of portal vein flow pulsatility in high-risk cardiac surgery patients: a multicentre prospective cohort study. Br J Anaesth. 2022 Nov;129(5):659-669. doi: 10.1016/j.bja.2022.07.053. Epub 2022 Sep 30.