Efficacy and tolerability of plasma exchange in patients with alcohol related acute on chronic liver failure-a pilot study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Change in following Clinical Severity Scores
研究概览
简要总结
ACLF is a complex syndrome characterized by highshort-term mortality. Liver transplantationis the only definitive treatment available. However,owing to variousfactors, majority of the patients are unfit for transplant.Artificial liver support systems like plasma exchange can be used as a bridgingtool to transplant. PE by removal of accumulating toxic mediators and byproviding an improvement in biochemical and clinical parameters stabilizes theclinical conditions related to liver failure.
Knowledge about the use of plasma exchange in acute onchronic failure is limited. Most of the data available are retrospectivelyanalysed conclusions. In this study, we would prospectively analyze theefficacy and tolerability of plasma exchange in patients with alcohol relatedchronic liver disease on their first episode of decompensation. This study mayprovide an evidence on the role of plasma exchange as an adjunctive modality intreatment of these patients, helping in early intervention along the course ofthe disease and thereby to better management of these patients.
We have planned a preliminary non-randomized interventional case-control pilot study. Considering the cost and limited numberof plasma exchanges that can be performed duringthe specified time period, the sample size of the study has been set at 30 patients only (15cases, 15 controls)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age more than 18 years 2.First episode of de-compensation with APASL ACLF Research Consortium (AARC)- ACLF grade I or II (AARC score ≤10) 3.Cause of ACLF being alcohol related liver disease 4.No evidence of active infection 5.Willing to give informed consent for the procedure(In patients who are incompetent to consent,consent shall be taken from the surrogate).
排除标准
- •1.Pregnancy 2.Causes of ACLF other than alcohol 3.Co-existing HCC or extra-hepatic malignancy 4.Microbiological or radiological evidence of active infection 5.Active hemorrhage 6.Extra-hepatic multi-organ failure (≥3 organ failures) 7.APASL-AARC score >10 8.Known allergy to Plasma, Protamine or Heparin.
- •9.Mechanically ventilated patients 10.Severe preexisting cardiopulmonary disease 11.Requiring inotropic support 12.Renal failure requiring dialysis 13.Severe systemic illness like HIV 14.Post liver transplant patients 15.Death within 24 hours of presentation.
结局指标
主要结局
1.Change in following Clinical Severity Scores
时间窗: Baseline, Day 10, Day 30 and Day 90
3. Mortality on Day 30 and Day 90
时间窗: Baseline, Day 10, Day 30 and Day 90
a)Maddrey’s discriminant function score (MDF) for alcoholic hepatitis
时间窗: Baseline, Day 10, Day 30 and Day 90
c)AARC score for ACLF
时间窗: Baseline, Day 10, Day 30 and Day 90
2. Clinical improvement based on LFT parameters
时间窗: Baseline, Day 10, Day 30 and Day 90
b)Model for end-stage liver disease(MELD score) and Child-Turcotte-Pugh(CTP)for alcoholic cirrhosis
时间窗: Baseline, Day 10, Day 30 and Day 90
d)SOF-C score(Simple Organ Failure count)
时间窗: Baseline, Day 10, Day 30 and Day 90
4. Duration of Hospital stay
时间窗: Baseline, Day 10, Day 30 and Day 90
次要结局
- 1. Cytokine assay:(a)IL-6& 10levels (Pre & Post plasma exchange therapy))