Acute Kidney Injury Clinical Trial
— VeXUSOfficial title:
Feasibility of a Randomised Trial Comparing a Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery: a Pilot Randomised Trial.
NCT number | NCT06251713 |
Other study ID # | 69HCL23_0891 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2024 |
Est. completion date | March 2025 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital cardiologique Louis Pradel | Bron | |
France | Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon | Bron |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Randomized controlled study feasibility | 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. | 48 hours after the inclusion | |
Secondary | Description of the "standard practice" group | 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. | 48 hours after the inclusion | |
Secondary | Description of deviations from the protocol in the "intervention" group" | 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. | 48 hours after the inclusion | |
Secondary | Venous congestion prevalence | Proportion of patients with VeXUS score >1 at the inclusion | Day 1 | |
Secondary | Haemodynamic instability occurrence | Occurrence of Mottling score>1 or capillary refill time>3s | Between inclusion and Hour 48 (H48) | |
Secondary | Severe metabolic disturbance occurrence | Occurrence of serum potassium <3mmol/L, serum sodium >150 mmol/L, arterial pH>7.55 with HCO3->40mmol/L | Day 2 | |
Secondary | Persistent acute Kidney Injury occurrence | Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups | 48 hours after the inclusion | |
Secondary | Use of Renal Replacement Therapy (RRT) occurrence | Description and comparison of the RRT requirement in the 2 groups | Day 30 (D30) | |
Secondary | Renal adverse events | Description and comparison of the 2 groups for the composite criteria : death or Renal Replacement therapy dependence or creatinine > 200% baseline creatinine. | Day 30 (D30) | |
Secondary | Acute kidney disease occurrence | 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. | Day 30 (D30) |
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