Copaci 2013.
| Methods | Open‐label, single‐centre randomised clinical trial. | |
| Participants |
Criteria used to define hepatorenal syndrome: not reported. Type 1 hepatorenal syndrome = 36 participants included. Type 2 hepatorenal syndrome = 4 participants included. Demographics: Terlipressin group: not available. Other vasoactive drug group: not available. |
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| Interventions |
Terlipressin: Administration form: continuous intravenous infusion. Dose: dose titration regimen. Initial dose 4 mg/24 hours. With no response, dose increased stepwise to 12 mg/24 hours. Response defined as a reduction in serum creatinine of ≥ 50% from baseline or reversal of hepatorenal syndrome. Other vasoactive drug:octreotide. Administration form: subcutaneously 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 ≥ 50% from baseline or reversal of hepatorenal syndrome. 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 | No description. Data on reversal of hepatorenal syndrome and mortality available. | |
| Treatment duration |
Treatment duration: data not available. Follow‐up: 30 days. |
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| Country of origin | Romania. | |
| Inclusion period | Data not available. | |
| Notes | Abstract. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description. |
| Allocation concealment (selection bias) | Unclear risk | No description. |
| 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 accounted for. |
| 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 | Unclear risk | No description. |
| Overall risk of bias (non‐mortality outcomes) | High risk | |
| Overall risk of bias (mortality) | High risk | |