Clinical trial NCT04388267: Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery
Official 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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 .


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of arterial elastance
timeFrame: 60 minutes
measure: Evolution of Stroke Volume (SV)
timeFrame: 60 minutes
Secondary outcomes:
measure: Evolution of Dicrotic Pressure (DP) value during a fluid challenge
timeFrame: 60 minutes
measure: Predictive factors of an increase or a decrease in the arterial elastance value
timeFrame: 60 minutes
measure: Predictive factors of an increase or a decrease of the dicrotic pressure value
timeFrame: 60 minutes
measure: Evolution of norepinephrine dose: before and 60 minutes after fluid challenge
timeFrame: 60 minutes
measure: All-cause mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU
Study officials:
affiliation: CHRU Nancy
name: Philippe Guerci, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: 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.
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