PVP-ETO-CPC
Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy
Sponsor study identifier
interventional
39
1 country
1
Study Start
May 26, 2017
Actual (reported)Primary Completion
May 24, 2018
Actual (reported)Study Completion
May 24, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 24, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2017
Actual (reported)May 26, 2017
Actual (reported)June 23, 2017
Actual (reported)May 24, 2018
Actual (reported)May 24, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350, France
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.
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.
MOORE ALEX, Dr
HOPITAL MARIE LANNELONGUE
First Submitted
May 21, 2017
First Posted
June 23, 2017
Study Start
May 26, 2017
Actual (reported)SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
May 24, 2018
Actual (reported)Study Completion
May 24, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 24, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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