Aortic Stenosis Clinical Trial
— RELASTANCEOfficial title:
Comparative Study on the Relationship Between Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or in the Postoperative Course of Aortic Surgery
The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua,
Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is
a noncalibrated pulse contour method which requires only an arterial line (radial or
femoral). This method has been validated in various clinical conditions. Among the collected
parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e.
cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as
arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation
to determine their interest in clinical practice. To date, it is rarely used to adapt
therapies, mostly because of a lack of knowledge regarding the evolution of these parameters.
The aim of this study is to analyze the relationship between the evolution of Arterial
Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5
minutes in patients with either septic shock or in the postoperative course of a major
vascular surgery.
Patients will be considered fluid responders if an increase >10% of the stroke volume is
observed .
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age at least 18 years - Septic shock (according to Sepsis-3 definition) or patients who underwent elective or emergent abdominal aortic surgery - Invasive blood pressure (radial or femoral) and Mostcare monitoring - Stroke volume between 20 and 50 mL/beat on the Mostcare system - Indication for a fluid challenge: hypotension (Mean arterial pressure under 65mmHg) or oliguria (urine flow rate < 0,5mL/kg/h for more than 12h), mottling, hyperlactatemia > 2 mmol/l Exclusion Criteria: - Age <18 years - Cardiac arrhythmia - Arterial wave form distortion - Inappropriate identification of the dicrotic notch for any reason - Refuse to consent to the study |
Country | Name | City | State |
---|---|---|---|
France | CHRU | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10. Review. Erratum in: J Appl Physiol. 2009 Mar;106(3):1027. — View Citation
Gopal S, Do T, Pooni JS, Martinelli G. Validation of cardiac output studies from the Mostcare compared to a pulmonary artery catheter in septic patients. Minerva Anestesiol. 2014 Mar;80(3):314-23. Epub 2014 Jan 8. — View Citation
Guarracino F, Baldassarri R, Pinsky MR. Ventriculo-arterial decoupling in acutely altered hemodynamic states. Crit Care. 2013 Mar 19;17(2):213. doi: 10.1186/cc12522. Review. — View Citation
Guarracino F, Ferro B, Morelli A, Bertini P, Baldassarri R, Pinsky MR. Ventriculoarterial decoupling in human septic shock. Crit Care. 2014 Apr 24;18(2):R80. doi: 10.1186/cc13842. — View Citation
Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772. — View Citation
Messina A, Romano SM, Bonicolini E, Colombo D, Cammarota G, Chiostri M, Della Corte F, Navalesi P, Payen D, Romagnoli S. Cardiac cycle efficiency and dicrotic pressure variations: new parameters for fluid therapy: An observational study. Eur J Anaesthesiol. 2017 Nov;34(11):755-763. doi: 10.1097/EJA.0000000000000661. — View Citation
Monge García MI, Guijo González P, Gracia Romero M, Gil Cano A, Oscier C, Rhodes A, Grounds RM, Cecconi M. Effects of fluid administration on arterial load in septic shock patients. Intensive Care Med. 2015 Jul;41(7):1247-55. doi: 10.1007/s00134-015-3898-7. Epub 2015 Jun 11. — View Citation
Morelli A, Singer M, Ranieri VM, D'Egidio A, Mascia L, Orecchioni A, Piscioneri F, Guarracino F, Greco E, Peruzzi M, Biondi-Zoccai G, Frati G, Romano SM. Heart rate reduction with esmolol is associated with improved arterial elastance in patients with septic shock: a prospective observational study. Intensive Care Med. 2016 Oct;42(10):1528-1534. doi: 10.1007/s00134-016-4351-2. Epub 2016 Apr 21. — View Citation
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18. — View Citation
Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. Review. — View Citation
Romagnoli S, Ricci Z, Romano SM, Dimizio F, Bonicolini E, Quattrone D, De Gaudio R. FloTrac/Vigileo(TM) (third generation) and MostCare(®)/PRAM versus echocardiography for cardiac output estimation in vascular surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1114-21. doi: 10.1053/j.jvca.2013.04.017. Epub 2013 Sep 19. — View Citation
Suga H. Time course of left ventricular pressure-volume relationship under various enddiastolic volume. Jpn Heart J. 1969 Nov;10(6):509-15. — View Citation
Sunagawa K, Maughan WL, Burkhoff D, Sagawa K. Left ventricular interaction with arterial load studied in isolated canine ventricle. Am J Physiol. 1983 Nov;245(5 Pt 1):H773-80. — View Citation
Walley KR. Left ventricular function: time-varying elastance and left ventricular aortic coupling. Crit Care. 2016 Sep 10;20:270. doi: 10.1186/s13054-016-1439-6. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evolution of arterial elastance | Absolute and percentage of change in arterial elastance during the study period | 60 minutes | |
Primary | Evolution of Stroke Volume (SV) | Absolute and percentage of change in stroke volume during the study period | 60 minutes | |
Secondary | Evolution of Dicrotic Pressure (DP) value during a fluid challenge | Absolute and percentage of change in dicrotic pressure during the study period | 60 minutes | |
Secondary | Predictive factors of an increase or a decrease in the arterial elastance value | Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the arterial elastance epidemiological and clinical: age, BMI, gender, SAPS II, SOFA, Charlson comorbidity index, chronic diseases, etiology of the septic shock, acute kidney injury therapeutical: chronic treatments, vasoactive and sedative drugs, epidural analgesia, mechanical ventilation (VT, RR, PEEP) surgery: type of surgery (open or endovascular), indication, timing. indication for fluid loading: hypotension, oliguria, hyperlactatemia > 2mmol/L, mottling |
60 minutes | |
Secondary | Predictive factors of an increase or a decrease of the dicrotic pressure value | Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the dicrotic pressure | 60 minutes | |
Secondary | Evolution of norepinephrine dose: before and 60 minutes after fluid challenge | Norepinephrine dose expressed in micrograms per kilogram per minute (µg/kg/min) | 60 minutes | |
Secondary | All-cause mortality | 30 days all-cause mortality | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04310046 -
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
|
N/A | |
Completed |
NCT03332745 -
Mechanism of Decompensation Evaluation - Aortic Stenosis
|
||
Recruiting |
NCT06008080 -
Post-Market Clinical Follow Up Study With Navitor Valve
|
||
Recruiting |
NCT06055751 -
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
|
||
Active, not recruiting |
NCT04815785 -
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
|
N/A | |
Terminated |
NCT02202434 -
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
|
N/A | |
Recruiting |
NCT03029026 -
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
|
||
Active, not recruiting |
NCT02903420 -
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
|
N/A | |
Completed |
NCT02629328 -
CardioCel Tri-leaflet Repair Study
|
N/A | |
Completed |
NCT02306226 -
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
|
||
Withdrawn |
NCT01648309 -
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
|
N/A | |
Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
Completed |
NCT01422044 -
Risk Prediction in Aortic Stenosis
|
N/A | |
Withdrawn |
NCT00774657 -
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
|
N/A | |
Terminated |
NCT00535899 -
Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
|
N/A | |
Terminated |
NCT05070130 -
OpSens PRIME CLASS
|
||
Completed |
NCT03314857 -
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
|
N/A | |
Completed |
NCT04157920 -
Impact of Predilatation Between Self-expanding Valves
|
N/A | |
Enrolling by invitation |
NCT06212050 -
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
|
||
Recruiting |
NCT05893082 -
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
|
N/A |