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

• Conditions: Shock, Septic; Hyperlactatemia; Oliguria; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Ruptured; Aortic Stenosis
• Interventions: Drug: Fluid challenge

• Registration Number: NCT04388267
• Lead Sponsor: Central Hospital, Nancy, 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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Status Verified: 2020-01
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-14
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic shock	Fluid challenge	Patients with septic shock, according to the Sepsis 3 definition, regardless of the origin
Major vascular surgery	Fluid challenge	Patients who underwent elective or emergent major vascular surgery abdominal aortic surgery (open or endovascular surgery)

Primary Outcome Measures

Name	Time	Method
Evolution of arterial elastance	60 minutes	Absolute and percentage of change in arterial elastance during the study period
Evolution of Stroke Volume (SV)	60 minutes	Absolute and percentage of change in stroke volume during the study period

Secondary Outcome Measures

Name	Time	Method
Predictive factors of an increase or a decrease of the dicrotic pressure value	60 minutes	Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the dicrotic pressure
Evolution of norepinephrine dose: before and 60 minutes after fluid challenge	60 minutes	Norepinephrine dose expressed in micrograms per kilogram per minute (μg/kg/min)
Predictive factors of an increase or a decrease in the arterial elastance value	60 minutes	Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the arterial elastance; * epidemiological and clinical: age, BMI, gender, SAPS II, SOFA, Charlson comorbidity index, chronic diseases, etiology of the septic shock, acute kidney injury; * therapeutical: chronic treatments, vasoactive and sedative drugs, epidural analgesia, mechanical ventilation (VT, RR, PEEP); * surgery: type of surgery (open or endovascular), indication, timing.; * indication for fluid loading: hypotension, oliguria, hyperlactatemia \> 2mmol/L, mottling
Evolution of Dicrotic Pressure (DP) value during a fluid challenge	60 minutes	Absolute and percentage of change in dicrotic pressure during the study period
All-cause mortality	30 days	30 days all-cause mortality

Trial Locations

Locations (1)

CHRU; 🇫🇷 Nancy, France