To Evaluate the Safety and Efficacy of Preemptive Administration of Continuous Renal Replacement Therapy in Patients With Acute Liver Failure With Cerebral Edema -A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Transplant free survival
研究概览
简要总结
In this prospective randomized controlled trial, investigator aim to evaluate the impact of early initiation of CRRT on outcomes in patients with acute liver failure with cerebral edema and hyperammonemia in improving cerebral edema and clinical outcomes. Investigator also aim to evaluate the effects of early initiation of CRRT on systemic hemodynamics (cardiac output and systemic vascular resistive index, extravascular lung water and lung permeability index), endothelial function and coagulation, microcirculation (as assessed by lactate clearance and central venous oxygen saturation), mitochondrial function. Patients with ALF who meet the inclusion and exclusion criteria.
Group 1: CRRT initiation within the first 12 hours Group 2: CRRT would be initiated i) In patients with worsening hyperammonemia despite two sessions of plasma-exchange ii) Patients meeting renal indications (hyperkalemia, volume overload, oliguria or metabolic acidosis etc)
详细描述
Hypothesis: Investigator hypothesize that preemptive administration of continuous renal replacement therapy would be synergistic to plasma-exchange in ameliorating the cytokine storm, cerebral edema and improve outcomes in patients with non-acetaminophen ALF with cerebral edema compared to late initiation.
Aim and Objective -
AIM:
Primary
- 21-day transplant free survival with Prometheus Secondary
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute liver failure defined patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease with documented cerebral edema on CT-scan and arterial ammonia >150 ug/dL.
排除标准
- •Age <18 or > 70 years
- •Hepatocellular Carcinoma
- •Active untreated Sepsis/DIC
- •Hemodynamic instability requiring high dose of vasopressors
- •Post-resection and malignancy related liver failure
- •Coma of non-hepatic origin
- •Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- •Patients already meeting emergency criteria for immediate initiation of dialysis 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
- •Pregnancy related liver failure
- •Patients with significant renal dysfunction meeting absolute criteria for initiation of dialysis
- •Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score >3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
- •Patients being taken up for liver transplant
- •Refusal to participate in the study.
结局指标
主要结局
Transplant free survival
时间窗: Day 21
次要结局
- Effect on systemic hemodynamics(Day 5)
- Effect on pulmonary function(Day 5)
- Duration of mechanical ventilation in both groups(28 days)
- Effect on pro-inflammatory cytokines.(5 days)
- Effect on DAMPS.(5 days)
- Effect on endothelial functions.(5 days)
- Impact on arterial lactate(Day 14)
- Effect on coagulation.(5 days)
- To study the safety of therapy (incidence of intradialytic hypotension, impairment of coagulation, hypothermia)(2 years)
- Improvement in SIRS(Day 5)
- Effect on endotoxin.(5 days)
- Improvement in cerebral edema and hepatic encephalopathy(Day 14)
- Duration of ICU stay in both groups(28 days)