Skip to main content
. 2017 Sep 27;2017(9):CD011532. doi: 10.1002/14651858.CD011532.pub2

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%.
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.
Outcomes Primary: reversal of hepatorenal syndrome.
Secondary: 3 months survival.
Treatment duration Treatment duration: until reversal of hepatorenal syndrome, death, or a maximum of 14 days.
Follow‐up: 3 months.
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