On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis -A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Recovery of renal functions in both groups
研究概览
简要总结
Intervention: All patients at presentation would be assessed for the underlying cause of and will be managed by removal of all precipitants(careful review of medications, diuretics, nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step would be to consider plasma volume expansion in patients with hypovolemia (the choice of fluid could either be a crystalloid or albumin or even blood as indicated) along with identification and early treatment of bacterial infections. Along with this patients with a differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis of ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further, patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid resuscitation and vasoconstrictors would also be subjected to randomization.
- In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization
- In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis (diagnosed based on clinical, biochemical,radiological or histological diagnosis) with stage 3 Acute Kidney Injury defined as an increase of serum creatinine to more than 300 fold and more than 4 mg/dl.
排除标准
- •Patients with age less than 18 years
- •Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD Chronic Obstructive Pulmonary Disease)
- •Pregnancy
- •Chronic kidney disease on hemodialysis
- •Patients with post renal obstructive AKI (Acute Kidney Injury), AKI (Acute Kidney Injury) suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- •Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization (serum potassium>6 meq/lt, metabolic acidosis ph<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
- •Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
- •Extremely moribund patients with an expected life expectancy of less than 24 hours
- •Failure to give informed consent from family members.
- •Hemodynamic instability requiring very high dose of vasopressors.
研究组 & 干预措施
Protocol Guided-RRT
In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization.
干预措施: Protocol Guided Renal Replacement Therapy (Biological)
On Demand-RRT
In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions
干预措施: On Demand Renal Replacement Therapy (Biological)
结局指标
主要结局
Recovery of renal functions in both groups
时间窗: day 14
次要结局
- Adverse effects of dialysis in the first session in both groups(48 hours)
- Improvement in SOFA (by 2 points) scores in both groups(48 hours)
- Improvement in MELD ( by 2 points) scores in both groups(48 hours)
- Improvement in APACHE ( by 2 points) scores in both groups(48 hours)
- Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups(4 weeks)
- Improvement in renal functions in both groups(7 days)
- Mortality in both groups(3 month)
- Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.(12 hours)
- Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury(24 hours)
- Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups(24 hours)
- Mortality in both groups(1 month)
- Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.(6 hours)