Sustained Low Efficiency Dialysis Versus Continuous Renal Replacement Therapy for Acute Kidney Injury in Critically Ill Cirrhotics-A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Development of intradialytic hypotension i.e. decrease in defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by 10 mm Hg after initiation of dialysis
研究概览
简要总结
The current prospective pliot randomized controlled trial has been designed to demonstrate non-inferiority of sustained low efficiency dialysis (SLED) when compared to continuous renal replacement therapy in managing AKI in context of cirrhotics with septic shock who are hemodynamically unstable. The patients would be randomized 1:1 to either SLED or CRRT after screening for the inclusion and exclusion criteria.
详细描述
Aim & Objectives
Primary objective To study the efficacy of sustained low efficiency dialysis versus continuous renal replacement therapy in cirrhotics with septic shock and severe AKI
Secondary Objectives Effects on renal recovery rates in the two groups To assess the effects on 7-day and 28-day mortality Efficacy on Lactate Clearance Duration of mechanical ventilation and ICU stay Effect on systemic hemodynamics and reversal of shock Clearance of endotoxin and pro-inflammatory cytokines Effect on coagulation and endothelial function Improvement in SOFA scores at 48 hours and day 5
Methodology All included patients would be randomised to receive either continuous renal replacement therapy or sustained low efficiency dialysis (SLED) Patients with septic shock would be screened. Following this, patients meeting the inclusion and exclusion criteria will be screened and randomized to the two treatment groups. Standard criteria will be considered to define refractoriness to fluids and initiation of dialysis. Fluid management would be performed using the dynamic indices in patients on mechanical ventilation or using IVC diameter and passive-leg rasing in non-intubated patients. In all patients, baseline endotoxin activity assay and blood and urine sample will be stored for looking at the effect of therapy on cytokine profile (TNF alpha, IL-IB, IL6, IFN-gamma, MCP-1, IL-10 and ADAMTS and vWillebrand factor). Septic shock would be defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L despite adequate volume resuscitation. The blood flow rate, dialysis flow rate and need of ultrafiltration would be recorded for all enrolled patients. Subsequent sessions of therapy would be done as per requirement and recorded. The dose of vasopressor in norepinephrine equivalent would be recorded for all patients at enrolment as under
Study Population:
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
- •Critically ill cirrhotics with septic shock defined as need of vasopressors to maintain MAP> 65 mm Hg and lacate >2 mmol/L despite adequate fluid resuscitation with severe AKI meeting criteria for dialysis
排除标准
- •Patients with age less than 18 years or more than 65 years
- •Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD, CKD)
- •Patients with ACLF
- •Patients with cerebral edema
- •Patients with refractory shock i.e. requiring norepinephrine or equivalent >0.5ug/kg/min
- •Severe coagulopathy platelets <20,000 and INR >4
- •Active Bleed (Mucosal or variceal)
- •Pregnancy
- •Patients with moderate-severe ARDS i.e. Pa02/Fio2 ratio <200
- •Extremely moribund patients with an expected life expectancy of less than 24 hours
- •Failure to give informed consent from family members.
- •Patient enrolled in other clinical trials
- •Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- •Patients who have already been on hemodialysis before their arrival in the intensive care unit
- •Patients with severe vasodilatation SVR <400 dyn·s/cm5 and/or lactate > 5 mmol/L
结局指标
主要结局
Development of intradialytic hypotension i.e. decrease in defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by 10 mm Hg after initiation of dialysis
时间窗: at 6 hours after dialysis initiation
次要结局
- Mortality in both groups(Day 28)
- Lactate clearance at 12 in both groups(12 hours)
- AKI recovery at day 14(Day 14)
- Renal failure related death at day 7(Day 7)
- Reversal of shock at 48 hours(48 hours)
- Duration of mechanical ventilation and ICU stay(Day 28)
- Lactate clearance at 24 hours in both groups(24 hours)