Alessandria 2007.
| Methods | Open‐label, single‐centre randomised clinical trial. | |
| Participants |
Criteria used to define hepatorenal syndrome:Arroyo 1996 (Appendix 2). Type 1 hepatorenal syndrome = 9 participants included. Type 2 hepatorenal syndrome = 13 participants included. Demographics: Terlipressin group: mean age 55 years, 75% men, alcoholic cirrhosis 33%. Other vasoactive drug group: mean age 56 years, 70% men, alcohol‐related cirrhosis 20%. |
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| Interventions |
Terlipressin: Administration form: intravenous bolus injection. Dose: dose titration regimen. Initial dose 1 mg/4 hours. With no response, dose increased to 2 mg/4 hours. Response defined as reduction in serum creatinine ≥ 25% from baseline after 3 days of treatment. Other vasoactive drug:noradrenaline. Administration form: continuous intravenous infusion. Dose: dose titration regimen. Initial dose 0.1 μg/kg/minute. Dose increased in steps of 0.05 μg/kg/minute every 4 hours until the mean arterial pressure was increased to at least 10 mmHg compared to baseline. Maximum dose 0.7 μg/kg/minute. Cointervention: Both arms treated with albumin to maintain a central venous pressure between 10 cmH2O and 15 cmH2O. Mean dose of albumin in terlipressin group. 46 g/day (range 35 to 65). Mean dose of albumin in noradrenaline group 56 g/day (range 40 to 75). During follow‐up, participants with ascites were treated with diuretics and large volume paracentesis followed by albumin infusions as needed. |
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| Outcomes | No predefined outcome (pilot study). Survival and reversal of hepatorenal syndrome reported. | |
| Treatment duration |
Treatment duration: until reversal of hepatorenal syndrome, death, or a maximum 2 weeks. Follow‐up: 90 days. |
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| Country of origin | Italy. | |
| Inclusion period | Data not available. | |
| Notes | Full paper. All survivors underwent liver transplantation at end of follow‐up. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description. |
| Allocation concealment (selection bias) | Low risk | Serially numbered sealed opaque envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. All participants included in analyses. |
| Selective reporting (reporting bias) | Low risk | Clinically relevant outcomes defined and reported. No differences between trial registration/protocol and published paper identified. |
| For‐profit bias | Low risk | No funding or other support from for‐profit organisations. |
| Overall risk of bias (non‐mortality outcomes) | High risk | |
| Overall risk of bias (mortality) | High risk | |