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

C

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

Trial contacts and locations

1

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Central trial contact

Nicolas Dellestable; Philippe Guerci, MD

Data sourced from clinicaltrials.gov

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