Rolando 1993.
Methods | Data collection: no information provided. Exclusion from analysis: bleeding not related to variceal bleeding. Follow‐up period: 7 days. | |
Participants | UK Hospitalised cirrhotic patients with upper gastrointestinal haemorrhage and high risk of infection, without infection, or treatment with antibiotics in the previous two weeks. Etiology of bleeding: all patients had oesophageal varices. Endoscopic sclerotherapy was performed after randomisation. Initial infection assessment: chest X‐ray, white blood cell count, urine/blood/ascites culture. Child‐Pugh class A/B/C: not reported. | |
Interventions | Experimental: intravenous imipenem + cilastin, 500 mg before and after the sclerotherapy. Control: intravenous dextrose‐saline solution. |
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Outcomes | Prevent bacterial infections. | |
Notes | Authors were contacted for the first version of this review, and additional information was received. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | The sequence was generated using a computer‐based table of random numbers. |
Allocation concealment? | Low risk | Patients assigned sequentially, sealed opaque envelopes used. |
Blinding? All outcomes | High risk | Not a blinded trial. |
Incomplete outcome data addressed? All outcomes | Low risk | Reassons for missing data are based on the violation of the protocol. |
Free of selective reporting? | Low risk | The report include all the expected outcomes. |
Free of other bias? | Unclear 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. |