Ghosh 2013.
| Methods | Open‐label, single‐centre randomised clinical trial. | |
| Participants |
Criteria used to define hepatorenal syndrome:Salerno 2007 (Appendix 2). Type 2 hepatorenal syndrome = 46 participants included. Demographics: Terlipressin group: mean age 46 years, 87% men, alcohol‐related cirrhosis 65%. Other vasoactive drug group: mean age 48 years, 70% men, alcohol‐related cirrhosis 70%. |
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| Interventions |
Terlipressin: Administration form: intravenous bolus injection. Dose: dose titration regimen. Initial dose 0.5 mg/6 hours. With no response, dose increased primarily to 1 mg/6 hours and then to 2 mg/6 hours. Response defined as a reduction in serum creatinine of 1 mg/dL after 3 days of treatment. Other vasoactive drug:noradrenaline. Administration form: continuous intravenous infusion. Dose: dose titration regimen. Initial dose 0.5 mg/hour. Dose increased in steps of 0.5 mg/hour every 4 hours until mean arterial pressure increased to ≥ 10 mmHg compared to baseline or an increase in urine output to > 200 mL/4 hours. Maximum dose 3 mg/hour. Cointervention: both arms treated with albumin 20 g/day to 40 g/day. Treatment temporarily stop if central venous pressure exceeded 18 cmH2O. |
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| Outcomes |
Primary: reversal of hepatorenal syndrome. Secondary: 3 months mortality. |
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| Treatment duration |
Treatment duration: until reversal of hepatorenal syndrome, death, or a maximum of 15 days. Follow‐up: 3 months. |
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| Country of origin | India. | |
| Inclusion period | January 2009 to December 2011. | |
| 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 | High risk | Investigators excluded 12 participants from analyses after randomisation. Reasons for exclusions/withdrawals included sepsis (7), severe coronary artery disease (1), hepatocellular carcinoma (1), diabetic nephropathy (1), and refusal to participate (2). Authors did not provide information about allocation group. |
| 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 | |