Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy (PVP-ETO-CPC)
Primary Purpose
Pulmonary Hypertension, Thromboembolism, Pulmonary, Perioperative/Postoperative Complications
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
All patients
Sponsored by
About this trial
This is an interventional screening trial for Pulmonary Hypertension focused on measuring Transesophageal ultrasound, TEE, Portal vein pulsatility, Splenic vein pulsatility, Venous congestion, Strain, Right ventricular dysfunction, Pulmonary hypertension, Venous hypertension
Eligibility 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
Sites / Locations
- Hopital Marie LannelongueRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary endarterectomy patients
Arm Description
All patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03197792
First Posted
May 21, 2017
Last Updated
April 23, 2019
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT03197792
Brief Title
Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy
Acronym
PVP-ETO-CPC
Official Title
Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Venous hypertension
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary endarterectomy patients
Arm Type
Experimental
Arm Description
All patients
Intervention Type
Other
Intervention Name(s)
All patients
Intervention Description
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 Measure Information:
Title
Persistent organ dysfunction plus death (POD + death) 7 days after surgery
Description
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.
Time Frame
On the morning of the 7th postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TRAORE AMINATA, CEC
Phone
+33140948664
Email
a.traore@ccml.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOORE ALEX, Dr
Organizational Affiliation
HOPITAL MARIE LANNELONGUE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TRAORE AMINATA, CEC
Phone
+33140948664
Email
a.traore@ccml.fr
First Name & Middle Initial & Last Name & Degree
MOORE ALEX, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24356157
Citation
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.
Results Reference
background
PubMed Identifier
26028638
Citation
Jenkins 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.
Results Reference
background
PubMed Identifier
2791245
Citation
Dittrich 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.
Results Reference
background
PubMed Identifier
20875129
Citation
Olson 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.
Results Reference
background
PubMed Identifier
25327878
Citation
Marston 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.
Results Reference
background
Learn more about this trial
Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy
We'll reach out to this number within 24 hrs