Cavallin 2016.
Methods | Open label, multicentre randomised clinical trial. | |
Participants |
Criteria used to define hepatorenal syndrome:Salerno 2007 (Appendix 2). Type 1 hepatorenal syndrome = 44 participants included. Type 2 hepatorenal syndrome = 4 participants included. Demographics: Terlipressin group: mean age 60 years, men 78%, viral aetiology 37%. Other vasoactive drug group: mean age 65 years, men 52%, viral aetiology 38%. |
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Interventions |
Terlipressin: Administration form: continuous intravenous infusion. Dose: dose titration regimen. Initial dose 3 mg/24 hours. With no response, dose primarily increased to 6 mg/24 hours and then to 12 mg/24 hours. Response defined as a reduction of serum creatinine of ≥ 25% compared to baseline after every 48 hours of treatment. Other vasoactive drugs:midodrine and octreotide Midodrine Administration form: oral tablet. Dose: dose titration regimen. Initial dose 7.5 mg/8 hours. With no response, dose increased to 12.5 mg/8 hours. Response defined as a reduction in serum creatinine of ≥ 25% from baseline after 3 days of treatment. Octreotide Administration form: subcutaneous bolus injection. Dose: dose titration regimen. Initial dose 100 mg/8 hours. With no response, dose increased to 200 mg/8 hours. Response defined as a reduction in serum creatinine of ≥ 25% from baseline after 3 days of treatment. Cointervention: both arms treated with albumin; 1 g/kg bodyweight at day 1, followed by 20 g/day to 40 g/day. |
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Outcomes |
Primary: reversal of hepatorenal syndrome. Secondary: 3 months survival. |
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Treatment duration |
Treatment duration: until reversal of hepatorenal syndrome, death, or a maximum of 14 days. Follow‐up: 3 months. |
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Country of origin | Italy. | |
Inclusion period | 2008 to 2012. | |
Notes | Full paper. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated allocation sequence. |
Allocation concealment (selection bias) | Low risk | Serially numbered opaque sealed 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 and all participants were accounted for. |
Selective reporting (reporting bias) | Low risk | Clinically relevant outcomes reported. No differences between trial registration/protocol and published paper identified. |
For‐profit bias | Low risk | Authors declared no conflict of interests and the trial did not receive funding from for‐profit organisations. |
Overall risk of bias (non‐mortality outcomes) | High risk | |
Overall risk of bias (mortality) | Low risk |