Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy

Not Applicable

• Conditions: Thromboembolism, Pulmonary; Pulmonary Hypertension; Perioperative/Postoperative Complications; Venous Hypertension; Cardiac Failure
• Interventions: Other: All patients

• Registration Number: NCT03197792
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-05-21
• Study Start: 2017-05-26
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-23
• Primary Completion: 2018-05-24
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24
• Study Completion: 2019-05-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary endarterectomy patients	All patients	All patients

Primary Outcome Measures

Name	Time	Method
Persistent organ dysfunction plus death (POD + death) 7 days after surgery	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.

Trial Locations

Locations (1)

Hopital Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France