The Clinical Significance of Portal Hypertension After Cardiac Surgery: a Multicenter Prospective Observational Study (TECHNO-MULTI)

• ClinicalTrials.gov Identifier: NCT03656263
• Recruitment Status: Completed
• First Posted: September 4, 2018
• Last Update Posted: February 24, 2021
• Sponsor: Montreal Heart Institute
• Information provided by (Responsible Party): Andre Denault, Montreal Heart Institute

Study Description

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.

Condition or disease	Intervention/treatment
Surgery--Complications; Congestive Heart Failure; Right Heart Failure; Anesthesia; Venous Congestion	Diagnostic Test: Doppler assessment of portal vein flow

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 360 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Clinical Significance of Portal Hypertension After Cardiac Surgery
• Actual Study Start Date: November 14, 2018
• Actual Primary Completion Date: February 20, 2021
• Actual Study Completion Date: February 20, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
High risk cardiac surgery patients; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing cardiac surgery at high risk for complications.

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

Contacts and Locations

Locations

Canada, Quebec

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

Montreal Heart Institute

Investigators

• Principal Investigator: André Denault, MD PhD; Montreal Heart Institute

More Information

• Responsible Party: Andre Denault, Principal investigator, Montreal Heart Institute
• ClinicalTrials.gov Identifier: NCT03656263
• Other Study ID Numbers: TECHNO-MULTI
• First Posted: September 4, 2018
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andre Denault, Montreal Heart Institute:

echocardiography; Portal Doppler; Cardiac surgery

Additional relevant MeSH terms:

Hypertension, Portal; Hypertension; Heart Failure; Hyperemia; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Liver Diseases; Digestive System Diseases