Advanced cirrhosis and haemorrhage Digestive System Liver cirrhosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 - 80 years 2. Haematemesis and/or melena within 24 hours prior to inclusion 3. Advanced cirrhosis as defined by the presence of two or more of the following signs of liver failure: 3.1. Severe malnutrition 3.2. Serum bilirubin greater than 3 mg/dl 3.3. Ascites and hepatic encephalopathy (grade 1 or more)
Exclusion criteria
Exclusion criteria: 1. Allergy to cephalosporins or quinolones 2. Presence of any of the following signs of infection: 2.1. Fever greater than 37.5°C 2.2. White blood cell count greater than 15,000 mm^3 2.3. Immature neutrophils greater than 500 mm^3 2.4. More than 15 leukocytes per field in the fresh urine sediment or data compatible with pneumonia on the chest x-ray 3. Treatment with antibiotics within two weeks prior to the hemorrhage (excluding oral norfloxacin for prophylaxis of spontaneous bacterial peritonitis [SBP]) 4. Previously diagnosed advanced hepatocelullar carcinoma (one nodule greater than 5 cm, three nodules with one greater than 3 cm or more than three nodules) and human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The end point of the study was to assess if intravenous ceftriaxone is more effective than oral norfloxacin in reducing the rate of bacterial infections within the first 10 days after the haemorrhage. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effects of treatment allocation on control bleeding and hospital survival. | — |
Countries
Spain