Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery
- Conditions
- Acute Kidney InjuryCardiac SurgeryVenous CongestionHemodynamic Stability
- Interventions
- Other: VeXUS score guided fluid management strategyOther: Usual care
- Registration Number
- NCT06251713
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VeXUS score guided fluid management VeXUS score guided fluid management strategy Fluid management: * Restrictive intake * Diuretic-induced fluid removal aiming for a diuresis of 2-4mL/Kg/h if VeXUS score \> 1 * During 24 to 48 hours Usual care Usual care Fluid management: * Usual care * at the discretion of the attending physician
- Primary Outcome Measures
Name Time Method Randomized controlled study feasibility 48 hours after the inclusion Percentage of patients recruited without deviations from the protocol (number of patients included per month) at the end of the recruitment and follow-up period, i.e. the number of patients who received the full initial treatment (48 hours) in accordance with the interventional protocol out of the number of patients eligible for the study.
- Secondary Outcome Measures
Name Time Method Venous congestion prevalence Day 1 Proportion of patients with VeXUS score \>1 at the inclusion
Persistent acute Kidney Injury occurrence 48 hours after the inclusion Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups
Renal adverse events Day 30 (D30) Description and comparison of the 2 groups for the composite criteria : death or Renal Replacement therapy dependence or creatinine \> 200% baseline creatinine.
Description of the "standard practice" group 48 hours after the inclusion The standard practice groupe will be describe. The description will be based on the number of patients concerned by the administration of diuretics, molecule and dosage used, reason for the administration of diuretics, cumulative fluid balance.
Use of Renal Replacement Therapy (RRT) occurrence Day 30 (D30) Description and comparison of the RRT requirement in the 2 groups
Description of deviations from the protocol in the "intervention" group" 48 hours after the inclusion To evaluation de faisability of the trial, the description of the deviations occurring in the intervention group will be based on the number of patients concerned, nature of the deviation from the protocol, cumulative fluid balance.
Acute kidney disease occurrence Day 30 (D30) Description and comparison of the 2 groups for the composite criteria : albuminuria or GFR \<60mL/min/1.73m or decrease of more than 35% in GFR.
Haemodynamic instability occurrence Between inclusion and Hour 48 (H48) Occurrence of Mottling score\>1 or capillary refill time\>3s
Severe metabolic disturbance occurrence Day 2 Occurrence of serum potassium \<3mmol/L, serum sodium \>150 mmol/L, arterial pH\>7.55 with HCO3-\>40mmol/L
Trial Locations
- Locations (2)
Hopital cardiologique Louis Pradel
🇫🇷Bron, France
Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon
🇫🇷Bron, France