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NCT Number: NCT03656263

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • Multiple surgical procedures planned
  • EuroSCORE II ≥ 5%
  • 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

Treatment and study plan

Doppler assessment of portal vein flow

Diagnostic Test

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

Primary outcomes

  1. Duration of invasive life support after cardiac surgery. (Tpod)

    Time frame: Up to 28 days

    Defined as the time of Persistent Organ Dysfunction (POD) or Death

Secondary outcomes

  1. All cause death

    Time frame: Up to 28 days

    Death from any cause

  2. Acute kidney injury according to KDIGO serum creatinine criteria

    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.

  3. Major bleeding defined by the Bleeding Academic Research Consortium (BARC)

    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

  4. Surgical reintervention for any reasons

    Time frame: Up to 28 days

    Re-operation after the initial surgery for any cause

  5. Deep sternal wound infection or mediastinitis

    Time frame: Up to 28 days

    Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician.

  6. Delirium

    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)

  7. Stroke

    Time frame: Up to 28 days

    A central neurologic deficit persisting longer than 72 hours

  8. Total duration of ICU stay in hours

    Time frame: Up to 28 days

    Number of hours passed in the ICU

  9. Duration of hospital stay (in days)

    Time frame: Up to 28 days

    Number of days hospitalized from the day of surgery to discharge

  10. Duration of mechanical ventilation (in hours)

    Time frame: Up to 28 days

    Number of hours of mechanical ventilation

  11. 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.

    Time frame: Up to 28 days

    Composite endpoint after cardiac proposed by the Society of Thoracic Surgeons

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

The Clinical Significance of Portal Hypertension After Cardiac Surgery

Acronym: TECHNO-MULTI

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2018
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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