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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Randomized controlled study feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VeXUS score guided fluid management
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
干预措施: VeXUS score guided fluid management strategy (Other)
Usual care
Fluid management:
- Usual care
- at the discretion of the attending physician
干预措施: Usual care (Other)
结局指标
主要结局
Randomized controlled study feasibility
时间窗: 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.
次要结局
- Venous congestion prevalence(Day 1)
- Persistent acute Kidney Injury occurrence(48 hours after the inclusion)
- Renal adverse events(Day 30 (D30))
- Description of the "standard practice" group(48 hours after the inclusion)
- Use of Renal Replacement Therapy (RRT) occurrence(Day 30 (D30))
- Description of deviations from the protocol in the "intervention" group"(48 hours after the inclusion)
- Acute kidney disease occurrence(Day 30 (D30))
- Haemodynamic instability occurrence(Between inclusion and Hour 48 (H48))
- Severe metabolic disturbance occurrence(Day 2)