NCT03656263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2.3 years

First QC Date

August 29, 2018

Last Update Submit

February 23, 2021

Conditions

Surgery--ComplicationsCongestive Heart FailureRight Heart FailureAnesthesiaVenous Congestion

Keywords

echocardiographyPortal DopplerCardiac surgery

Outcome Measures

Primary Outcomes (1)

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

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

    Up to 28 days

Secondary Outcomes (11)

  • All cause death

    Up to 28 days

  • Acute kidney injury according to KDIGO serum creatinine criteria

    Up to 28 days

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

    Up to 28 days

  • Surgical reintervention for any reasons

    Up to 28 days

  • Deep sternal wound infection or mediastinitis

    Up to 28 days

  • +6 more secondary outcomes

Study Arms (1)

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

Interventions

Doppler assessment of portal vein flowDIAGNOSTIC_TEST

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

High risk cardiac surgery patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing cardiac surgery at high risk for complications.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36184294DERIVED

MeSH Terms

Conditions

Heart FailureHyperemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • André Denault, MD PhD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 4, 2018

Study Start

November 14, 2018

Primary Completion

February 20, 2021

Study Completion

February 20, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)