Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery (NCT04388267) | Clinical Trial Compass
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Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery
France80 participantsStarted 2019-02-26
Plain-language 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 .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.