To Study the Natural History and Prognosis of Patients with Acute- On-Chronic Liver Failure [ACLF): A Multicentric Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To study the acute and chronic insult which have impact on outcomes of ACLF
研究概览
简要总结
Upon receiving the consent from the patient, Following data is to be collected as follows:
Clinical history and examination
Mode of decompensation
Etiology of acute event
Etiology of chronic event
Severity assessment indices
Complications if any
Investigations
Hematology
CBC, Prothrombin time and INR, Peripheral smear, Reties Biochemistry
Liver function testing, AFP
Kidney function test
Etiology of acute event:
Infectious etiology: IgM anti HAY , lgM anti HEY, lgM anti HBc ( If HBsAg +ve), lgM anti HDY ( If HBsAg +ve), HEY RNA
Non Infectious etiology: Alcohol binging in last 4 weeks, hepatotoxic drugs, ANA (> 1: 80), lgG, surgeries in past 4 weeks. acute variceal bleed within 4 weeks
Etiology of underlying chronic liver disease :
Infectious etiology: total anti HBc, anti HCY, HCY RNA, HBY DNA
Non infectious etiology: Autoimmune markers, copper studies, iron studies.
HOMA IR, FBS
Ascitic fluid analysis
UGI endoscopy and liver biopsy as needed
Any other investigations as per clinical need and judgement of physician
Imaging
USG abdomen with Doppler for spleno-portal axis OR CECT- Triple phase upper abdomen
Follow-up
Treatment will be done as per treating physician
Physical examination will be done daily, after I week and at 4 weeks, at 2 months, at 3 months and at 6 months
CBC on alternate day for 1 week, at end of I week and then at end of 4 weeks at 2 months, at 3 months and at 6 months
KFT on alternate day for 1 week, at end of 1 week and then at end of 4 weeks, at 2 months, at 3 months and at 6 months
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with acute hepatic insult manifesting as jaundice (Sr. Bi l.
- •5 mg/dL) and coagulopathy (INR 1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.
排除标准
- •Age less than 18 and more than 75 years HCC or Extra-hepatic malignancy Pregnancy Patients being taken up for transplant Refusal to participate in the study.
结局指标
主要结局
To study the acute and chronic insult which have impact on outcomes of ACLF
时间窗: Day 0, Day 4, Day 7, Day 30, Day 180 and Day 365
次要结局
- To study the acute and chronic insults which have an impact on outcome of ACLF(To study whether sepsis is a cause or effect of ACLF and define the Golden therapeutic window)
研究者
Dr Shiran Shetty
Manipal Academy of Higher Education