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. 2010 Sep 8;2010(9):CD002907. doi: 10.1002/14651858.CD002907.pub2

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.
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.