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

NCT03197792 | Unknown

• 1 other identifier: P17-37813005
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

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; Venous hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  On the morning of the 7th postoperative day

Study Arms (1)

Pulmonary endarterectomy patients

EXPERIMENTAL

All patients

Other: All patients

Interventions

All patients OTHER

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.

Pulmonary endarterectomy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Elective or urgent pulmonary endarterectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 24356157 BACKGROUND

• 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.

  PMID: 26028638 BACKGROUND

• 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.

  PMID: 2791245 BACKGROUND

• 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.

  PMID: 20875129 BACKGROUND

• 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.

  PMID: 25327878 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Embolism; Postoperative Complications; Heart Failure; Hyperemia; Sprains and Strains; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Embolism; Embolism and Thrombosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Wounds and Injuries; Ventricular Dysfunction

Study Officials

• MOORE ALEX, Dr

  HOPITAL MARIE LANNELONGUE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TRAORE AMINATA, CEC

CONTACT

+33140948664; a.traore@ccml.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of thoracic surgery

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: June 23, 2017
• Study Start: May 26, 2017
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)