Srivastava 2015.
Methods | Open‐label, single‐centre randomised clinical trial. | |
Participants |
Criteria used to define hepatorenal syndrome:Salerno 2007 (Appendix 2). Type 1 hepatorenal syndrome = 40 participants included. Type 2 hepatorenal syndrome = 40 participants included. Demographics: type 1 hepatorenal syndrome. Terlipressin group: mean age 46 years, 83% men, alcohol‐related cirrhosis 50%. Other vasoactive drug group: mean age 39 years, 83% men, alcohol‐related cirrhosis 50%. Demographics: type 2 hepatorenal syndrome. Terlipressin group: mean age 45 years, 83% men, alcohol‐related cirrhosis 53%. Other vasoactive drug group: mean age 43 years, 83% men, alcohol‐related cirrhosis 55%. |
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Interventions |
Terlipressin: Administration form: intravenous bolus injection. Dose: fixed dose 0.5 mg/6 hours. Other vasoactive drug:dopamine and furosemide. Administration form: continuous intravenous infusion. Dose: fixed doses of dopamine 2 μg/kg/minute and furosemide 0.01 mg/kg/hour. Cointervention: both arms treated with albumin 20 g/day. |
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Outcomes |
Primary outcomes: reversal of hepatorenal syndrome, 15 and 30 days' survival. Secondary outcomes: cost of treatment. |
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Treatment duration |
Treatment duration: 5 days. Follow‐up: 30 days. |
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Country of origin | India. | |
Inclusion period | February 2005 to June 2010. | |
Notes | Full paper. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers. |
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 included in analyses. |
Selective reporting (reporting bias) | High risk | Number of participants with (or without) reversal of hepatorenal syndrome not reported. |
For‐profit bias | Low risk | Authors declared no conflict of interests. The randomised clinical trial received financial support from the Indian Council of Medical Research and did not receive funding from for‐profit organisations. |
Overall risk of bias (non‐mortality outcomes) | High risk | |
Overall risk of bias (mortality) | High risk |