Surgery--ComplicationsTECHNO-MULTINCT03656263
The Clinical Significance of Portal Hypertension After Cardiac Surgery: a Multicenter Prospective Observational Study
An observational study of Surgery--Complications and Congestive Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications, Congestive Heart Failure, Right Heart Failure
- What is being tested?
- Doppler assessment of portal vein flow
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- 14 Nov 2018to 20 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery at high risk for complications.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Significance of Portal Hypertension After Cardiac Surgery
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.
Read the 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.
- Conditions
- Surgery--Complications, Congestive Heart Failure, Right Heart Failure, Anesthesia, Venous Congestion
- Being tested
- Doppler assessment of portal vein flow
- Keywords
- echocardiography, Portal Doppler, Cardiac surgery
- Medical subject headings
- Heart Failure, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler assessment of portal vein flowDiagnostic test
Doppler assessment of portal vein flow using peri-operative trans-esophageal echography before and after cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Doppler assessment of portal vein flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of invasive life support after cardiac surgery. (Tpod)
Defined as the time of Persistent Organ Dysfunction (POD) or Death
Measured: Up to 28 days
Secondary outcomes (11)
All cause death
Death from any cause
Measured: 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.
Measured: 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
Measured: Up to 28 days
Surgical reintervention for any reasons
Re-operation after the initial surgery for any cause
Measured: 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.
Measured: 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)
Measured: Up to 28 days
Stroke
A central neurologic deficit persisting longer than 72 hours
Measured: Up to 28 days
Total duration of ICU stay in hours
Number of hours passed in the ICU
Measured: Up to 28 days
Duration of hospital stay (in days)
Number of days hospitalized from the day of surgery to discharge
Measured: Up to 28 days
Duration of mechanical ventilation (in hours)
Number of hours of mechanical ventilation
Measured: 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
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start14 Nov 2018
- Primary completion20 Feb 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Denault, Montreal Heart Institute
- Investigators
- André Denault, MD PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656263
- Sponsor's protocol ID
- TECHNO-MULTI
- Acronym
- TECHNO-MULTI
- Status last verified
- Feb 2021
- First submitted
- 29 Aug 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36184294
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Portal Hypertension After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03656263
- Acronym / sponsor ID
- TECHNO-MULTI / TECHNO-MULTI
- Conditions
- Surgery--Complications, Congestive Heart Failure, Right Heart Failure, Anesthesia, Venous Congestion
- Keywords
- echocardiography, Portal Doppler, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk cardiac surgery patients | – | Diagnostic Test: Doppler assessment of portal vein flowDefined as either: * Multiple surgical procedures planned and/or, * EuroSCORE ≥ 5% and/or, * Known pulmonary hypertension (mPAP>25 mmHg or sPAP > 40 mmHg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery at high risk for complications.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler assessment of portal vein flowDoppler assessment of portal vein flow using peri-operative trans-esophageal echography before and after cardiopulmonary bypass. | Diagnostic test | High risk cardiac surgery patients |
Primary outcome
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
11 secondary outcomes
All cause death
Time frame: Up to 28 days
Acute kidney injury according to KDIGO serum creatinine criteria
Time frame: Up to 28 days
Major bleeding defined by the Bleeding Academic Research Consortium (BARC)
Time frame: Up to 28 days
Surgical reintervention for any reasons
Time frame: Up to 28 days
Deep sternal wound infection or mediastinitis
Time frame: Up to 28 days
Delirium
Time frame: Up to 28 days
Stroke
Time frame: Up to 28 days
Total duration of ICU stay in hours
Time frame: Up to 28 days
Duration of hospital stay (in days)
Time frame: Up to 28 days
Duration of mechanical ventilation (in hours)
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.
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 36184294Denault 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Denault, MD PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications and Congestive Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of invasive life support after cardiac surgery. (Tpod) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.