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

Central Hospital, Nancy, France

Status: Unknown

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

Treatments: Drug: Fluid challenge

Study type: Observational

Funder types: Other

Identifiers

NCT04388267

PSS2018/RELASTANCE-GUERCI/YB

Details and patient eligibility

About

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 .

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Septic shock

Description:

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

Treatment:

Drug: Fluid challenge

Major vascular surgery

Description:

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

Treatment:

Drug: Fluid challenge