RAI & HRS: Relationship Between Relative Adrenal Insufficiency and Failure of Treatment in Hepatorenal Syndrome: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Response to treatment
研究概览
简要总结
Hepatorenal syndrome is a life-threatening medical condition and a serious complication of advanced liver scarring (cirrhosis). It consists of a deterioration of the function of the kidneys caused by a severe alteration in the circulation (blood flow to the kidneys) due to liver cirrhosis. Only around half of the patients respond to treatment which consists of intravenous medication. Moreover, the adrenal glands, which are located on the kidneys, also suffer an alteration in the blood flow leading to deterioration in their function as well. Thus, these patients produced less cortisol than needed; this situation is called "relative adrenal insufficiency". Cortisol is an important hormone necessary in extreme situations such as severe diseases. This is a study which will assess the relationship between the presence of adrenal dysfunction and failure to treatment in patients with hepatorenal syndrome.
详细描述
This is a prospective, observational, descriptive, clinical study.
This is a single centre study. All patients admitted to the South West Liver Unit with decompensated cirrhosis will be screened according to their serum creatinine (sCr) level taken as part of standard of care at admission or during their hospitalization.
All patients with AKI stage 2-3 or with stage 1 and serum Creatinine >133 µmol/L who give consent to participate or consent is given by legal representative. Patients should meet all the inclusion criteria and none exclusion criteria.
The consent can be received by a medical doctor or by a research nurse involved in the study. The details will be recorded on the study delegation log.
Patients will be followed up during admission. Decompensation episodes including development of hepatic encephalopathy, worsening ascites, jaundice, GI bleeding related to portal hypertension, and infections will be recorded during follow up. Follow up finishes when the patient is discharged.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects capable of giving informed consent, or in case of lack of capacity, their legal representative consent on their behalf.
- •Older than 18 years old and younger than 80 years old.
- •Diagnosis of cirrhosis according to liver biopsy, or non-invasive markers (Fibroscan) or a combination of clinical and imaging criteria.
- •Diagnosis of AKI stage 2-3 or stage 1 with serum Creatinine > 133 µmol/L, according to the last international consensus (International Club of Ascites, 2015)
排除标准
- •Advanced hepatocellular carcinoma, Barcelona-Clinic liver cancer (BCLC) stage C or D
- •Infection by human immunodeficiency virus (HIV)
- •Previous transplant or any other type of immunodeficiency
- •Pregnancy
- •Long-term treatment with steroids or other immunosuppressive agents or interferon
- •Severe chronic heart failure, New York Heart Association (NYHA), class III or IV
- •Advanced COPD, global initiative for chronic obstructive lung disease (GOLD) III or IV
- •Renal failure on haemodialysis
- •Any medical condition that gives a survival shorter than 3 months
结局指标
主要结局
Response to treatment
时间窗: Between days 5 to 14 after treatment has started
Reduction in sCr with terlipressin in patients with hepatorenal syndrome between patients with and without relative adrenal insufficiency. \*\* Definition of response to treatment: Response to treatment is defined as a reduction of at least 25% from pre-treatment value. Full response is met when final sCr returns to a value lower than 26 µmol/L above the baseline value. Partial response is met when final sCr returns to a value higher than 26 µmol/L above the baseline value. Always with a reduction of sCr of at least 25% from pre-treatment value.
次要结局
- Hospital Mortality Rates(Through study completion an average of 20 months)
- Circulatory Dysfunction(At baseline)
- Degree of Inflammation(At baseline)
- Bacterial Translocation(At baseline)