Pulmonary Hypertension Clinical Trial
— PVP-ETO-CPCOfficial title:
Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy
NCT number | NCT03197792 |
Other study ID # | P17-37813005 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 26, 2017 |
Est. completion date | May 24, 2019 |
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.
Status | Recruiting |
Enrollment | 39 |
Est. completion date | May 24, 2019 |
Est. primary completion date | May 24, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital Marie Lannelongue | Le Plessis Robinson |
Lead Sponsor | Collaborator |
---|---|
Centre Chirurgical Marie Lannelongue |
France,
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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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