Singh 2012.
| Methods | Open‐label, single‐centre randomised clinical trial. | |
| Participants |
Criteria used to define hepatorenal syndrome:Salerno 2007 (Appendix 2). Type 1 hepatorenal syndrome = 46 participants included. Demographics: Terlipressin group: mean age 51 years, 83% men, alcohol‐related cirrhosis 43%. Other vasoactive drug group: mean age 48 years, 83% men, alcohol‐related cirrhosis 52%. |
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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 stepwise to maximum 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 stopped if central venous pressure exceeded 18 cmH2O. Participants with tense ascites had 3 L to 5 L paracentesis combined with infusions of 8 g of albumin for each litre of ascitic fluid removed. |
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| Outcomes |
Primary outcome: reversal of hepatorenal syndrome. Secondary outcomes: 30 days survival. |
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| Treatment duration |
Treatment duration: until reversal of hepatorenal syndrome, death, or a maximum of 15 days. Follow‐up: 30 days. |
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| Country of origin | India. | |
| Inclusion period | January 2009 to 2011 October. | |
| Notes | Full paper. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated allocation list. |
| 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 included in analyses. |
| 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 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 | |