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
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Thromboembolism, Pulmonary Perioperative/Postoperative Complications Venous Hypertension Cardiac Failure||Other: All patients||Not Applicable|
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)|
|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|
Experimental: Pulmonary endarterectomy 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.
- 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.
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
|Contact: TRAORE AMINATA, CECfirstname.lastname@example.org|
|Hopital Marie Lannelongue||Recruiting|
|Le Plessis Robinson, France, 92350|
|Contact: TRAORE AMINATA, CEC +33140948664 email@example.com|
|Principal Investigator: MOORE ALEX, Dr|
|Principal Investigator:||MOORE ALEX, Dr||HOPITAL MARIE LANNELONGUE|