Pulmonary HypertensionPVP-ETO-CPCNCT03197792
Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy
A study testing All patients in people with Pulmonary Hypertension and Thromboembolism, Pulmonary, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death in patients undergoing elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Thromboembolism, Pulmonary, Perioperative/Postoperative Complications
- What is being tested?
- All patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2017to 24 May 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Elective or urgent pulmonary endarterectomy
Who cannot join
- absolute or relative contraindication to the use of transesophageal echocardiography,
- hepatic cirrhosis,
- portal vein thrombosis,
- concomitant coronary artery bypass grafting,
- patient refusal or unable to give informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
TRAORE AMINATA, CEC, +33140948664, a.traore@ccml.fr
MOORE ALEX, Dr
About this study
Official title: Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy
The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death in patients undergoing elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. The investigators' hypothesis is that the portal vein pulsatility fraction, measured using transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is proportional to the risk of developing subsequent end-organ dysfunction in the postoperative setting.
Read the detailed description
While transesophageal echocardiography is recommended in patients with known or suspected cardiovascular pathology which may impact outcomes, no study has evaluated it's perioperative use in pulmonary endarterectomy surgery.
Most pulmonary endarterectomy patients suffer from severe pulmonary hypertension, right heart dysfunction and central venous hypertension. Postoperative complications are closely related to the importance of residual postoperative pulmonary hypertension and right ventricular dysfunction. A portal vein pulsatility fraction of 50% or more in the perioperative setting might indicate right ventricular dysfunction and/or hypervolemia-related severe venous congestion, which may be responsible for multiple organ dysfunction and significant morbidity or mortality in critically ill patients.
The investigators believe pulmonary endarterectomy patients with a high portal vein pulsatility fraction immediately after weaning from cardiopulmonary bypass have a greater risk of developing postoperative persistent organ dysfunction and/or death. In this prospective descriptive study, the investigators will evaluate portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death 7 days after pulmonary endarterectomy.
Left and right global longitudinal strain after weaning from cardiopulmonary bypass will also be evaluated as potential indicators of a higher risk of persistent organ dysfunction plus death 7 days after surgery.
- Conditions
- Pulmonary Hypertension, Thromboembolism, Pulmonary, Perioperative/Postoperative Complications, Venous Hypertension, Cardiac Failure
- Being tested
- All patients
- Keywords
- Transesophageal ultrasound, TEE, Portal vein pulsatility, Splenic vein pulsatility, Venous congestion, Strain, Right ventricular dysfunction, Pulmonary hypertension, Venous hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Embolism, Postoperative Complications, Heart Failure, Hyperemia, Sprains and Strains, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patientsOther
TEE is performed before cardiopulmonary bypass (before the opening of the pericardium, if possible) and immediately after weaning from cardiopulmonary bypass and optimization of the hemodynamic status by the attending anesthesiologist. A detailed ultrasound examination including portal vein pulsatility, splenic vein pulsatility, right and left ventricular global longitudinal strain and right and left systolic and diastolic function is recorded. A measure of portal vein pulsatility using TTE is also recorded before the onset of general anesthesia and on the morning of the 7th postoperative day.
On the 7th postoperative day, the investigators will evaluate for the presence of the primary outcome, POD + death.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary endarterectomy patients | Experimental | All patients Receives: Other: All patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent organ dysfunction plus death (POD + death) 7 days after surgery
POD + death, defined as death or one of the following criterias (yes or no) present on the 7th postoperative day : (1) mechanical ventilation (excluding non-invasive ventilation) without breaks for more than 48 hours, (2) ongoing need for vasopressor therapy more than 2 hours per day (dopamine more than 5 mcg/kg/min, phenylephrine more than 50 mcg/min, norepinephrine, epinephrine, vasopressin), (3) ongoing need for mechanical circulatory support such as ECMO or IABP, and (4) continuous renal replacement therapy or new intermittent hemodialysis.
Measured: On the morning of the 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start26 May 2017
- Primary completion24 May 2018
- Study completion24 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with chronic post-embolic pulmonary hypertension eligible to pulmonary endarterectomy surgery will be evaluated for venous congestion and right ventricular failure after weaning of cardiopulmonary bypass, and followed until the 7th postoperative day for the development of postoperative organ dysfunction and/or death.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olaf Mercier, MD, PhD, Centre Chirurgical Marie Lannelongue
- Investigators
- MOORE ALEX, Dr, Principal investigator, HOPITAL MARIE LANNELONGUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197792
- Sponsor's protocol ID
- P17-37813005
- Acronym
- PVP-ETO-CPC
- Status last verified
- Apr 2019
- First submitted
- 21 May 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH; American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. Anesth Analg. 2014 Jan;118(1):21-68. doi: 10.1213/ANE.0000000000000016. No abstract available.
PubMed 24356157Jenkins D. Pulmonary endarterectomy: the potentially curative treatment for patients with chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015 Jun;24(136):263-71. doi: 10.1183/16000617.00000815.
PubMed 26028638Dittrich HC, Chow LC, Nicod PH. Early improvement in left ventricular diastolic function after relief of chronic right ventricular pressure overload. Circulation. 1989 Oct;80(4):823-30. doi: 10.1161/01.cir.80.4.823.
PubMed 2791245Olson N, Brown JP, Kahn AM, Auger WR, Madani MM, Waltman TJ, Blanchard DG. Left ventricular strain and strain rate by 2D speckle tracking in chronic thromboembolic pulmonary hypertension before and after pulmonary thromboendarterectomy. Cardiovasc Ultrasound. 2010 Sep 27;8:43. doi: 10.1186/1476-7120-8-43.
PubMed 20875129Marston N, Brown JP, Olson N, Auger WR, Madani MM, Wong D, Raisinghani AB, DeMaria AN, Blanchard DG. Right ventricular strain before and after pulmonary thromboendarterectomy in patients with chronic thromboembolic pulmonary hypertension. Echocardiography. 2015 Jul;32(7):1115-21. doi: 10.1111/echo.12812. Epub 2014 Oct 18.
PubMed 25327878
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy
- ClinicalTrials.gov ID
- NCT03197792
- Acronym / sponsor ID
- PVP-ETO-CPC / P17-37813005
- Conditions
- Pulmonary Hypertension, Thromboembolism, Pulmonary, Perioperative/Postoperative Complications, Venous Hypertension, Cardiac Failure
- Keywords
- Transesophageal ultrasound, TEE, Portal vein pulsatility, Splenic vein pulsatility, Venous congestion, Strain, Right ventricular dysfunction, Pulmonary hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2019 (estimated)
- First posted
- 23 Jun 2017 (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.
The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death in patients undergoing elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. The investigators' hypothesis is that the portal vein pulsatility fraction, measured using transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is proportional to the risk of developing subsequent end-organ dysfunction in the postoperative setting.
Detailed description
While transesophageal echocardiography is recommended in patients with known or suspected cardiovascular pathology which may impact outcomes, no study has evaluated it's perioperative use in pulmonary endarterectomy surgery.
Most pulmonary endarterectomy patients suffer from severe pulmonary hypertension, right heart dysfunction and central venous hypertension. Postoperative complications are closely related to the importance of residual postoperative pulmonary hypertension and right ventricular dysfunction. A portal vein pulsatility fraction of 50% or more in the perioperative setting might indicate right ventricular dysfunction and/or hypervolemia-related severe venous congestion, which may be responsible for multiple organ dysfunction and significant morbidity or mortality in critically ill patients.
The investigators believe pulmonary endarterectomy patients with a high portal vein pulsatility fraction immediately after weaning from cardiopulmonary bypass have a greater risk of developing postoperative persistent organ dysfunction and/or death. In this prospective descriptive study, the investigators will evaluate portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death 7 days after pulmonary endarterectomy.
Left and right global longitudinal strain after weaning from cardiopulmonary bypass will also be evaluated as potential indicators of a higher risk of persistent organ dysfunction plus death 7 days after surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with chronic post-embolic pulmonary hypertension eligible to pulmonary endarterectomy surgery will be evaluated for venous congestion and right ventricular failure after weaning of cardiopulmonary bypass, and followed until the 7th postoperative day for the development of postoperative organ dysfunction and/or death.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary endarterectomy patients | Experimental | Other: All patientsAll patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Elective or urgent pulmonary endarterectomy
Key exclusion criteria (5 listed)
- absolute or relative contraindication to the use of transesophageal echocardiography,
- hepatic cirrhosis,
- portal vein thrombosis,
- concomitant coronary artery bypass grafting,
- patient refusal or unable to give informed consent
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 |
|---|---|---|
| All patientsTEE is performed before cardiopulmonary bypass (before the opening of the pericardium, if possible) and immediately after weaning from cardiopulmonary bypass and optimization of the hemodynamic status by the attending anesthesiologist. A detailed ultrasound examination including portal vein pulsatility, splenic vein pulsatility, right and left ventricular global longitudinal strain and right and left systolic and diastolic function is recorded. A measure of portal vein pulsatility using TTE is also recorded before the onset of general anesthesia and on the morning of the 7th postoperative day. On the 7th postoperative day, the investigators will evaluate for the presence of the primary outcome, POD + death. | Other | Pulmonary endarterectomy patients |
Primary outcome
Persistent organ dysfunction plus death (POD + death) 7 days after surgery
Time frame: On the morning of the 7th postoperative day
POD + death, defined as death or one of the following criterias (yes or no) present on the 7th postoperative day : (1) mechanical ventilation (excluding non-invasive ventilation) without breaks for more than 48 hours, (2) ongoing need for vasopressor therapy more than 2 hours per day (dopamine more than 5 mcg/kg/min, phenylephrine more than 50 mcg/min, norepinephrine, epinephrine, vasopressin), (3) ongoing need for mechanical circulatory support such as ECMO or IABP, and (4) continuous renal replacement therapy or new intermittent hemodialysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Background: PubMed 24356157Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH; American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. Anesth Analg. 2014 Jan;118(1):21-68. doi: 10.1213/ANE.0000000000000016. No abstract available.
- Background: PubMed 26028638Jenkins D. Pulmonary endarterectomy: the potentially curative treatment for patients with chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015 Jun;24(136):263-71. doi: 10.1183/16000617.00000815.
- Background: PubMed 2791245Dittrich HC, Chow LC, Nicod PH. Early improvement in left ventricular diastolic function after relief of chronic right ventricular pressure overload. Circulation. 1989 Oct;80(4):823-30. doi: 10.1161/01.cir.80.4.823.
- Background: PubMed 20875129Olson N, Brown JP, Kahn AM, Auger WR, Madani MM, Waltman TJ, Blanchard DG. Left ventricular strain and strain rate by 2D speckle tracking in chronic thromboembolic pulmonary hypertension before and after pulmonary thromboendarterectomy. Cardiovasc Ultrasound. 2010 Sep 27;8:43. doi: 10.1186/1476-7120-8-43.
- Background: PubMed 25327878Marston N, Brown JP, Olson N, Auger WR, Madani MM, Wong D, Raisinghani AB, DeMaria AN, Blanchard DG. Right ventricular strain before and after pulmonary thromboendarterectomy in patients with chronic thromboembolic pulmonary hypertension. Echocardiography. 2015 Jul;32(7):1115-21. doi: 10.1111/echo.12812. Epub 2014 Oct 18.
- 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.
MOORE ALEX, Dr principal investigator
HOPITAL MARIE LANNELONGUE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All patients in people with Pulmonary Hypertension and Thromboembolism, Pulmonary, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Apr 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TRAORE AMINATA, CEC (+33140948664, a.traore@ccml.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent organ dysfunction plus death (POD + death) 7 days after surgery (time frame: On the morning of the 7th postoperative day). 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 NCT03197792, which also lists 5 linked publications.
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 Apr 2019.