Pauwels 1996.
Methods | Data collection: 12/89 to 03/92. Exclusion from analysis: infection on admission, undergoing surgery within 24 hs after admission, or death in the first 12 h. Follow‐up period: up to 10 days after stopping bleeding (four weeks). | |
Participants | France
Hospitalised cirrhotic patients with upper gastrointestinal haemorrhage, without infection, or treatment with antibiotics in the previous week.
Etiology of bleeding: oesophageal or gastric varices, gastric or duodenal ulceration, and others. Initial infection assessment: chest X‐ray, white blood cell count, urine/blood/ascites culture. Source of bleeding determined by endoscopy scheduled within 12 hs after enrolment. Emergency sclerotherapy performed for patients bleeding from varices. Child‐Pugh class A/B/C: 16/54/49. |
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Interventions | Experimental (Group III): intravenous + oral ciprofloxacin 400mg per day, amoxicillin‐clavulanic acid 3g per day, until three days after cessation of haemorrhage. Control (Group I and II): no antibiotic prophylaxis. |
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Outcomes | Prevention of bacterial infections. | |
Notes | Two group of patients received no intervention and were combined for the purpose of this review. Authors were contacted for the first version of this review. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | The sequence was generated using a table of random numbers. |
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 exclusion of the patients was based on an exclusion rule. |
Sample calculation? | High risk | No sample calculation procedure. |