Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase (NCT06227702) | Clinical Trial Compass
UnknownNot Applicable
Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase
200 participantsStarted 2024-02-01
Plain-language summary
It is well recognized the association between fluid volume administered and positive fluid balance with adverse outcomes . Active fluid removal is widely practiced in an attempt to mitigate this potential damage. However, it is not clear which is the best approach for the post-resuscitation phase in critically ill patients. In this context, Point-of-Care ultrasound (POCUS) through Venous Excess Ultrasound (VExUS) would allow the assessment of the degree of venous congestion, through the visualization of vascular anatomy and blood velocity using Doppler, being potentially useful to guide fluid removal. The investigators will evaluate whether fluid management after the initial phase of VExUS-guided resuscitation is able to improve outcomes compared to usual therapy in patients with septic shock.
This is a single center, prospective, open and randomized clinical study in which patients admitted to intensive care will be included after the first 24 hours of resuscitation. A total of 200 patients will be randomized either to volume management guided by VExUS or to the standard therapy arm as per usual practice.
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 over 18 years old.
* Hospitalization in ICU for at least 48 hours.
* Patient in septic shock for at least 24 hours and clinically stable defined by mean arterial pressure ≥ 65 mmHg and maximum infusion of 0.20 μg/kg/min of norepinephrine and lactate \< 4.0 mmol/L.
* Signed informed consent
Exclusion Criteria:
* Patients in use of more than one vasopressor
* Known right ventricle dysfunction
* Indication to use furosemide for other reasons
* Hypernatremia (Na \>160 mmol/L)
* Advanced acute kidney injury(KDIGO 3)
* Current renal replacement therapy
* Anuria for ≥ 6 hours
* Hepatorenal syndrome
* Patients in palliative care
* Furosemide allergy.
* Rhabdomyolysis.
* Major burn
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 uses something called 'VExUS' to guide how much fluid I receive after the initial resuscitation phase of septic shock — can you explain what VExUS is and whether you think that approach could be relevant to my care?
2The study is measuring outcomes like death in the ICU, need for kidney dialysis, and creatinine levels on day three — does that tell us anything about how serious the decisions around fluid management are in my situation, and what approach you'd take if I'm not in this trial?
3The trial's recruitment status is listed as 'unknown,' which makes it hard to know if it's even actively enrolling — do you know whether this study is still open at any nearby center, and if not, are there similar studies I should look into?
4Since this trial is categorized as 'Phase NA,' meaning it's not a standard drug-testing phase trial, can you help me understand what that means for what's already known about the safety and potential benefit of VExUS-guided fluid management compared to standard care?
5If I were considered for this trial, what would participation actually look like day-to-day in the ICU — for example, how would decisions about my fluid levels be made differently than they would be under your usual standard of care for septic shock?
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
Hierarchy outcome: death in the ICU, need for renal replacement therapy during ICU stay and serum creatinine value on the third day after randomization