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Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy (PVP-ETO-CPC)

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ClinicalTrials.gov Identifier: NCT03197792
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Olaf Mercier, MD, PhD, Centre Chirurgical Marie Lannelongue

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Thromboembolism, Pulmonary Perioperative/Postoperative Complications Venous Hypertension Cardiac Failure Other: All patients Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Screening
Official Title: Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : May 24, 2018
Estimated Study Completion Date : May 24, 2019

Arm Intervention/treatment
Experimental: Pulmonary endarterectomy patients
All patients
Other: All patients

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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Elective or urgent pulmonary endarterectomy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197792


Contacts
Contact: TRAORE AMINATA, CEC +33140948664 a.traore@ccml.fr

Locations
France
Hopital Marie Lannelongue Recruiting
Le Plessis Robinson, France, 92350
Contact: TRAORE AMINATA, CEC    +33140948664    a.traore@ccml.fr   
Principal Investigator: MOORE ALEX, Dr         
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
Principal Investigator: MOORE ALEX, Dr HOPITAL MARIE LANNELONGUE

Publications:

Responsible Party: Olaf Mercier, MD, PhD, Professor of thoracic surgery, Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03197792     History of Changes
Other Study ID Numbers: P17-37813005
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
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 Olaf Mercier, MD, PhD, Centre Chirurgical Marie Lannelongue:
Transesophageal ultrasound
TEE
Portal vein pulsatility
Splenic vein pulsatility
Venous congestion
Strain
Right ventricular dysfunction
Pulmonary hypertension
Venous hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Thromboembolism
Postoperative Complications
Heart Failure
Pulmonary Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Pathologic Processes
Heart Diseases
Embolism