Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Ca… (NCT06251713) | Clinical Trial Compass
RecruitingNot Applicable
Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery
France40 participantsStarted 2024-07-31
Plain-language summary
Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if \<48h, persistent if \>48h), the development of acute kidney and chronic renal failure. Each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. Fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. Venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. An ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. Whether using the VeXUS score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated.
Before designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.
Who can participate
Age range
18 Years – 85 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:
* Intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation
* Acute kidney injury defined by KDIGO criteria
* Vasoactive inotropic score \<45 and capillary refill time \<3s
* Informed written consent
Exclusion Criteria:
* Hypokalaemia \<3.5mmol/L
* Hyponatremia\<125mmol/L
* Hypernatremia \>145mmol/L
* Metabolic alkalosis with pH \>7.50
* Impossibility to measure capillary refill time
* Chronic liver disease
* Cirrhosis with portal hypertension
* Known thrombus of the inferior vena cava
* Mechanical circulatory assistance (ECMO or mono left ventricular assistance)
* Severe pre-operative chronic kidney disease (GFR \< 30mL/min/1.73m2)
* Need for renal replacement therapy anticipated by the attending physician within 24 hours
* Known hypersensitivity to Furosemide and/or hydrochlorothiazide
* Severe allergy to wheat
* Patient already included in another interventional study with an exclusion period still in progress
* Pregnant, breast-feeding or women of childbearing age without suitable contraception
* Patients under guardianship, curatorship or safeguard of justice
* Patients under psychiatric care
* Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
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.