Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Mechanically Ven… (NCT06495489) | Clinical Trial Compass
CompletedNot Applicable
Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Mechanically Ventilated Patients Under Spontaneous Mode
France34 participantsStarted 2024-01-29
Plain-language summary
The management of septic shock patients includes the infusion of fluids, however fluids may be deleterious if the patient does not respond by increasing cardiac output. By consequence, it is now recommended to predict the fluid response (fluid or preload responsiveness) before infusing them. In this protocol, the investigators will include critically ill patients mechanically ventilated patients under a spontaneous mode, for whom the physician in charge has decided to test preload responsiveness. The investigators will collect from the continuous monitoring of arterial pressure of the patient the Pulse Pressure (PP) which is the difference between systolic arterial pressure and diastolic arterial pressure and the Pulse Pressure Variation (PPV) automatically displayed by the monitor in addition to other clinical (hemodynamic, respiratory) parameters. After one minute of Passive Leg Raising manoeuvre (PLR) the investigators collect the same parameters and the investigators will compare the changes of these parameters in patients who are preload responsive to patients who are not. Preload responsiveness will be defined by echocardiographic parameters before and during PLR. More exactly, a surrogate of cardiac output measured by echocardiography wich is VTI of the sub-aorti flow; an increase of more than 12% defines apreload responsive patient.
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:
* Patient over 18 years old.
* Hospitalized in intensive care.
* For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:
* Acute circulatory failure with mean arterial pressure \< 65mmHg or \< 30mmHg of its baseline value for hypertensive patients.
* And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia).
* In mechanically ventilated patients under spontaneous mode.
* Previously equipped with an arterial catheter.
* Affiliated to a social security scheme.
Exclusion Criteria:
* Patient with arrythmia (PPV is not applicable).
* Patient with intra-abdominal hypertension (PLR test is not valid).
* Patient with a contraindication/impossibility to the PLR maneuver (lower limb amputation, respiratory intolerance).
* Patient with poor echogenicity noted previously.
* Patient protected by law.
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.
What they're measuring
1
Diagnostic performance of the decrease in Pulse Pressure Variation (PPV) during a Passive Leg Raising test (PLR) to predict preload responsiveness