NCT02034279终止4 期
Albumin Administration in the Prevention of Hepatorenal Syndrome and Death in Patients With Cirrhosis, Bacterial Infections Other Than Spontaneous Bacterial Peritonitis and High Risk of Hospital Mortality
EASL - CLIF Consortium1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
The aim of this study is to evaluate whether albumin administration improves short-term survival in patients with advanced cirrhosis and bacterial infections other than Spontaneous Bacterial Peritonitis (SBP).
详细描述
The aim of this study is to evaluate if IV albumin administration improves short-term survival in patients with advanced cirrhosis (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l -milliequivalents per liter- and/or serum bilirubin ≥4 mg/dl) and bacterial infections other than spontaneous bacterial peritonitis (urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection).
Primary goals of the study:
• Effect of albumin administration on hospital survival
Secondary goals of the study:
- Effect of albumin administration on 28-day and 90-day survival.
- Effect of albumin administration on the incidence of renal dysfunction, AKI, type-1 and 2 Hepatorenal Syndrome (HRS) during hospitalization.
- Effect of albumin on circulatory function estimated by changes in plasma levels of renin and noradrenaline and in serum levels of lactate among infection diagnosis, day 3 and infection resolution.
- Effect of albumin on serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and nitric oxide (NOX) and on plasma levels of von Willebrand factor (vWF:Ag) at diagnosis and resolution of infection.
- Effect of albumin on blood leukocyte count and serum C-reactive protein levels (CRP) during infection.
- Effect of albumin on the development of other individual organ failures (renal, liver, cerebral, circulatory, coagulation and respiratory), acute-on-chronic liver failure (ACLF type 1, 2 and 3 according to the Canonic Study), CLIF-SOFA score, CLIF-Consortium score, Child-Pugh score and MELD score during hospitalization.
- Evaluation of predictive factors of HRS and ACLF development in non-SBP infections.
- Samples (blood, plasma, serum and urine) will be obtained and stored for genomic, proteomic and standard biochemical investigations in future ancillary studies related to the aim of the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients with age ≥18 years
- •Diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization
- •Patients with uncomplicated urinary infections or suspected bacterial infection will require the presence of signs of systemic inflammation: at least 1 diagnostic criterion of systemic inflammatory response syndrome (SIRS) and serum CRP levels ≥1 mg/dl (10 mg/L). This criterion will not be required for the rest of infections
- •Analytical data of renal and/or liver dysfunction (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l, serum bilirubin ≥4 mg/dl). Patients with pneumonia or documented bacteremia (positive blood cultures) will require the presence of at least 1 of these analytical criteria to be included in the study. Patients with urinary infection, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will require 2 or more criteria for inclusion
排除标准
- •> 72h after infection diagnosis
- •Pregnancy
- •Acute or subacute liver failure without underlying cirrhosis
- •Septic shock
- •Severe acute respiratory distress syndrome (Pa02/Fi02 ≤ 100)
- •Active or recent variceal bleeding unless controlled for > 48h
- •Ongoing type-1 HRS (past IAC criterion: serum creatinine ≥ 2.5 mg/dl)
- •Type-3 ACLF (defined according to the Canonic Study criteria)
- •Hemodialysis or other renal replacement therapy
- •Evidence of current malignancy (except for hepatocellular carcinoma within Milan criteria or non-melanocytic skin cancer)
- •Moderate or severe chronic heart (NYHA class II, III or IV) or pulmonary disease (GOLD IV)
- •Severe psychiatric disorders
- •Previous liver transplantation
- •HIV infection (except for patients under antiretroviral therapy with undetectable viral load, CD4>200/mm3 and no history of opportunistic infections diagnostic of AIDS)
- •Contraindications to albumin (allergy, signs of pulmonary edema)
- •Albumin administration (≥ 80g) in the last 2 days
- •Spontaneous bacterial peritonitis coinfection
- •Use of any investigational drug within 90 days prior to randomization
- •Refusal to participate
- •Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent
- •Physician and team not committed to intensive care if needed.
研究组 & 干预措施
Intravenous infusion of albumin
Experimental
Treatment arm will receive intravenous albumin on days 1 and 3 plus antibiotics
干预措施: Albumin (Drug)
结局指标
主要结局
survival
时间窗: hospitalization
Hospital survival will be the primary outcome
次要结局
- survival(28-d and 90-day survival)
- Renal dysfunction(hospitalization (expected average 2 weeks))
- circulatory dysfunction(day 3 and day of infection resolution)
- Inflammation and endothelial function(day of infection resolution)
- subsequent organ failure(hospitalization (expected average 2 weeks))
研究者
研究点 (1)
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Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.EUCTR2013-002416-27-BEFundacio Clinic per a la recerca biomedica512
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Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.Male and female cirrhotic patients with advanced cirrhosis (serum creatinine = 1.2 mg/dl, serum sodium = 130 mEq/l and/or serum bilirubin =4 mg/dl), and diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization.MedDRA version: 18.1Level: LLTClassification code 10008954Term: Chronic liver disease and cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10009213Term: Cirrhosis of liverSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2013-002416-27-DEFundacio Clinic per a la Recerca Biomedica512
进行中（未招募）
不适用
Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.EUCTR2013-002416-27-NOFundacio Clinic per a la recerca biomedica512
进行中（未招募）
不适用
Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.Patients with advanced cirrhosis (serum creatinine ? 1.2 mg/dl, serum sodium ? 130 mEq/l and/or serum bilirubin ?4 mg/dl), signs of systemic inflammation and urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will be includedMedDRA version: 16.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10008954Term: Chronic liver disease and cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10009213Term: Cirrhosis of liverSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2013-002416-27-ESFundacio Clinic per a la recerca biomedica512