Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery
NCT ID: NCT04388267
Last Updated: 2020-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2019-02-26
2020-07-31
Brief Summary
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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 .
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Septic shock
Patients with septic shock, according to the Sepsis 3 definition, regardless of the origin
Fluid challenge
All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe.
During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion.
The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.
Major vascular surgery
Patients who underwent elective or emergent major vascular surgery abdominal aortic surgery (open or endovascular surgery)
Fluid challenge
All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe.
During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion.
The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.
Interventions
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Fluid challenge
All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe.
During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion.
The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.
Eligibility Criteria
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Inclusion Criteria
* 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
* Cardiac arrhythmia
* Arterial wave form distortion
* Inappropriate identification of the dicrotic notch for any reason
* Refuse to consent to the study
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Philippe Guerci, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU Nancy
Locations
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CHRU
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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. No abstract available.
Romagnoli S, Ricci Z, Romano SM, Dimizio F, Bonicolini E, Quattrone D, De Gaudio R. FloTrac/Vigileo(TM) (third generation) and MostCare((R))/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.
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.
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.
Monge Garcia MI, Guijo Gonzalez 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.
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.
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.
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. doi: 10.1152/ajpheart.1983.245.5.H773.
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. No abstract available.
Suga H. Time course of left ventricular pressure-volume relationship under various enddiastolic volume. Jpn Heart J. 1969 Nov;10(6):509-15. doi: 10.1536/ihj.10.509. No abstract available.
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.
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.
Walley KR. Left ventricular function: time-varying elastance and left ventricular aortic coupling. Crit Care. 2016 Sep 10;20(1):270. doi: 10.1186/s13054-016-1439-6.
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.
Other Identifiers
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PSS2018/RELASTANCE-GUERCI/YB
Identifier Type: -
Identifier Source: org_study_id
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