Navasa 1996.
Methods | Randomised clinical trial | |
Participants | Country: Spain Number randomised: 132 Post‐randomisation dropouts: 9 Revised sample size: 123 Average age: 59 years Females: 44 (35.8%) Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): both Alcohol‐related cirrhosis: both Viral‐related cirrhosis: not stated Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated Other causes for cirrhosis: both Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated Follow‐up in months: 0.5 Years of recruitment: 1992‐1994 Exclusion criteria
|
|
Interventions | Participants were randomly assigned to two groups. Group 1: ofloxacin (n = 64) Further details: ofloxacin 100 mg/day to 800 mg/day depending upon creatinine levels (4 days to 2 weeks) Group 2: cefotaxime (n = 59) Further details: cefotaxime 1 g/day to 8 g/day depending upon creatinine levels (4 days to 2 weeks) | |
Outcomes | Outcomes reported
|
|
Notes | We were unable to locate the current contact details of the author. Reason for post‐randomisation dropouts: secondary peritonitis, voluntary dropout |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed with sealed envelopes containing the treatment options prepared with random numbers generated by the SAS statistical package (SAS Institute Inc., Cary, NC)". |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was performed with sealed envelopes containing the treatment options prepared with random numbers generated by the SAS statistical package (SAS Institute Inc., Cary, NC)". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: this information was not available. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: there were post‐randomisation dropouts; it is not clear whether this was related to treatment and/or outcomes. |
Selective reporting (reporting bias) | Low risk | Comment: a prepublished protocol was not available but the authors report routinely measured clinical outcomes adequately. |
Other bias | Low risk | Comment: no other bias was noted. |