Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients (NCT04963686) | Clinical Trial Compass
CompletedNot Applicable
Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients
France80 participantsStarted 2021-09-20
Plain-language summary
The assessment of left ventricular systolic function is based on the measurement of left ventricular ejection function (LVEF) by the Simpson biplane method. More recently, left ventricular global longitudinal strain (GLS) has been developed to detect abnormalities of cardiac contractility in patients with preserved myocardial contractility. However, both tools are not always easy to collect in practice. This is why other ultrasound parameters have been proposed in the literature as a substitute for LVEF and GLS such as the Doppler tissue imaging (DTI)-derived mitral annular systolic peak S-wave velocity (S'), the mitral annular plane systolic excursion (MAPSE) and the longitudinal wall fractional shortening index (LWFS).
The purpose of this project is to propose an algorithm using simple parameters (S' wave, lateral MAPSE, septal MAPSE, mean MAPSE and LWFS) to predict LVEF and GLS in order to diagnose patients with impaired systolic function and preserved ejection.
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:
* Patients hospitalized in the Medical Intensive Care Department of the Amiens-Picardie University Hospital for the management of septic shock.
* Septic shock is defined by sepsis with a need for vasopressor amines to maintain a mean arterial pressure higher than or equal to 65 mmHg, and associated with hyperlactatemia (higher than 2 mmol/L).
* A transthoracic echocardiography should be performed within 72 hours of the diagnosis of septic shock.
Exclusion Criteria:
* Patient with cardiac arrhythmias,
* patients with severe mitral or aortic valve disease,
* patients with fused mitral Doppler flow,
* patients with insufficient echogenicity to allow a correct assessment of left ventricular systolic function.
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.
1This trial was focused on testing a simplified way to assess heart function in people with septic shock — does that kind of simplified echo assessment get used at this hospital, and could it apply to my care?
2Since the study compared a simplified echocardiographic algorithm against standard measures like LVEF and GLS, can you explain what my own heart function measurements look like and which method was used to assess them?
3This trial has already been completed — are the results published yet, and if so, do they suggest the simplified approach is reliable enough to influence how my heart function would be monitored during septic shock treatment?
4Because this study was observational and focused on measurement accuracy rather than testing a new treatment, does it change any of the actual treatment options available to me, or is it more about improving how doctors monitor patients like me?
5Given that septic shock can affect the heart in serious ways, what tools does my care team currently use to track my left ventricular function, and would the findings from this kind of research change anything about my monitoring plan?
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.
What they're measuring
1
Concordance between LVEF and echocardiographic algorithm
Timeframe: 3 months
2
Concordance between GLS and echocardiographic algorithm