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.
- Conditions
- 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: 17.0Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 17.0Level: LLTClassification code 10008954Term: Chronic liver disease and cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 17.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 17.0Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 17.0Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 17.0Level: LLTClassification code 10009213Term: Cirrhosis of liverSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-002416-27-AT
- Lead Sponsor
- Medical University of Graz, Department of Internal Medicine, Division of Gastroenterology and Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 512
- Age between 18 and 79 years.
- Diagnosis of liver cirrhosis established by histology or by the combination of clinical, analytical and ultrasonographic data.
- Clinical data of systemic inflammation indicated by the presence of at least 1 diagnostic criterion of SIRS and high serum CRP levels (= 2 mg/dL or 20 mg/L).
- Diagnosis of urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization. Diagnostic criteria at inclusion will be the following: (a) urinary infections: more than 10 leukocytes per high-power field in urine or a positive reagent strip; (b) pneumonia: presence of new infiltrates on chest x-ray; (c) skin/soft tissue infection: physical exam findings of swelling, erythema, heat and tenderness in the skin; (d) acute cholangitis: cholestasis, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction and (e) suspected bacterial infection: signs of infection but no identifiable origin of this infection (polymorphonuclear cells in ascitic and pleural fluid < 250/mm3, normal urine sediment and chest X-ray).
- Presence of renal and/or liver dysfunction (serum creatinine =1.2 mg/dl, serum bilirubin =4 mg/dl or serum sodium = 130 mEq/l). Patients with pneumonia will require the presence of at least 1 of these analytical criteria to be included in the study. Two or more criteria will be required in patients with urinary infection, skin/soft tissue infection, acute cholangitis or suspected bacterial infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 362
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
- > 48h after the diagnosis of infection.
- Pre-menopausal women (last menstruation = 12 months prior to enrolment) who are nursing or pregnant or are of child bearing potential and are not practicing an acceptable method of birth control.
- Acute or subacute liver failure without underlying cirrhosis.
- Septic shock (mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation and need of vasopressor drugs).
- Acute respiratory distress syndrome [PaO2/Fi02 =200 or a pulse oximetric saturation (SpO2) to FiO2 ratio =214].
- Gastrointestinal bleeding in the last 5 days.
- Biopsy proven severe acute alcoholic hepatitis requiring specific treatment.
- Type-1 HRS (IAC criteria: serum creatinine = 2.5 mg/dl).
- Type-3 ACLF.
- Intrinsic nephropathy (proteinuria, hematuria or abnormal findings on renal ultrasonography) with renal failure (serum creatinine chronically = 1.5 mg/dl).
- Renal replacement therapy.
- Arterial hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg).
- 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).
- Severe pulmonary disease (GOLD III or IV).
- Severe psychiatric disorders.
- Any immunosuppressive drug.
- HIV infection.
- Contraindications to albumin (allergy, signs of pulmonary edema)
- Administration of any dose of IV albumin or albumin dialysis in the last 10 days
- Clinical indication for albumin use at inclusion (spontaneous bacterial peritonitis coinfection, large volume paracentesis)
- 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.
All patients meeting the inclusion criteria will be entered on a screening log. If the patient is not enrolled, the screening log will include information explaining why enrollment did not occur.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method