Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery

NCT04388267 | Unknown

• 1 other identifier: PSS2018/RELASTANCE-GUERCI/YB
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Shock, Septic; Hyperlactatemia; Oliguria; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Ruptured; Aortic Stenosis

Keywords

Mostcare; Vascular surgery; Arterial Elastance; Dicrotic pressure; Fluid loading; Pressure Recording Analytical Method; Hemodynamic monitoring; Pulse contour analysis

Outcome Measures

Primary Outcomes (2)

• Evolution of arterial elastance

  Absolute and percentage of change in arterial elastance during the study period

  60 minutes

• Evolution of Stroke Volume (SV)

  Absolute and percentage of change in stroke volume during the study period

  60 minutes

Secondary Outcomes (5)

• Evolution of Dicrotic Pressure (DP) value during a fluid challenge

  60 minutes

• Predictive factors of an increase or a decrease in the arterial elastance value

  60 minutes

• Predictive factors of an increase or a decrease of the dicrotic pressure value

  60 minutes

• Evolution of norepinephrine dose: before and 60 minutes after fluid challenge

  60 minutes

• All-cause mortality

  30 days

Study Arms (2)

Septic shock

Patients with septic shock, according to the Sepsis 3 definition, regardless of the origin

Drug: Fluid challenge

Major vascular surgery

Patients who underwent elective or emergent major vascular surgery abdominal aortic surgery (open or endovascular surgery)

Drug: Fluid challenge

Interventions

Fluid challenge DRUG

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; Septic shock

Eligibility Criteria

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

Study Population

The study population is a mix of septic shock and patients who underwent elective or emergent major vascular surgery surgery (aortic mostly) requiring a fluid challenge because of hypotension and/or oliguria and/or mottling and/or hyperlactatemia\>2mmol/L. All patients will be hospitalized in the surgical intensive care unit (ICU) of the University Hospital of Nancy Brabois, France.

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Cardiac arrhythmia
• Arterial wave form distortion
• Inappropriate identification of the dicrotic notch for any reason
• Refuse to consent to the study

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU

Nancy, 54000, France

RECRUITING

Related Publications (14)

• 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.

  PMID: 28012725 BACKGROUND

• 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.

  PMID: 24055563 BACKGROUND

• 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.

  PMID: 24398442 BACKGROUND

• 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.

  PMID: 28722695 BACKGROUND

• 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.

  PMID: 26077088 BACKGROUND

• 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.

  PMID: 28101605 BACKGROUND

• 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.

  PMID: 18617626 BACKGROUND

• 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.

  PMID: 6638199 BACKGROUND

• 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.

  PMID: 23510336 BACKGROUND

• 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.

  PMID: 5308142 BACKGROUND

• 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.

  PMID: 24762124 BACKGROUND

• 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.

  PMID: 27101380 BACKGROUND

• 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.

  PMID: 27613430 BACKGROUND

• 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.

  PMID: 29019850 BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Hyperlactatemia; Oliguria; Aortic Aneurysm, Abdominal; Aortic Rupture; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm, Ruptured; Rupture; Wounds and Injuries; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction

Study Officials

• Philippe Guerci, MD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Guerci, MD

CONTACT

+33 3 83 15 79 95; p.guerci@chru-nancy.fr

Nicolas Dellestable

CONTACT

+33 6 18 85 05 26; nico.dellestable@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: February 26, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-01

Locations

FR (1)