Fernandez 2006.
Methods | Data collection 02/2000 to 04/2004. Exclusion from analysis: occult infection (positive blood cultures obtained prior to randomisation) and less than two signs of liver failure (Norfloxacin group 6/63; Ceftriaxone group 7/61). Follow‐up period: 10 days. | |
Participants | Spain Multicenter trial on hospitalised patients in patients with cirrhosis and upper gastrointestinal haemorrhage. Etiology of bleeding: portal hypertension related in 77% of participants. Initial infection assessment: blood cultures, ascitic fluid polymorphonuclear count, urine sediment and culture, chest X‐ray. Emergency endoscopy within 24 h after onset of the haemorrhage, plus somatostatin or terlipressin on portal hypertension related haemorrhage. Sclerotherapy or banding was performed to stop bleeding. Chil‐Pugh class A/B/C: 0/52/59. |
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Interventions | Experimental: intravenous ceftriaxone 1g per day for 7 days. Control: oral norfloxacin 400 mg b.i.d. for 7 days. |
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Outcomes | Prevention of bacterial infections. | |
Notes | The authors were contacted via e‐mail and response was received (28‐June‐2010). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | The sequence was generated using a random number software. |
Allocation concealment? | Unclear risk | No information provided. |
Blinding? All outcomes | High risk | Not a blinded trial. |
Incomplete outcome data addressed? All outcomes | Low risk | Missing data are balanced in number across the intervention groups. |
Free of selective reporting? | Low risk | The report include all the expected outcomes. |
Free of other bias? | Low risk | The trial appears to be free of other sources of bias. |
Intention to treat analysis? | High risk | The excluded participants are balanced and with a justifiable reason. |
Sample calculation? | Low risk | The sample was calculated considering the expected incidence of proved and possible infections. |