Badawy 2013.
| Methods | Open‐label multicentre randomised clinical trial. | |
| Participants |
Criteria used to define hepatorenal syndrome:Arroyo 1996 (Appendix 2). Type 1 hepatorenal syndrome = 51 participants included. Demographics: Terlipressin group: mean age 43 years, 67% men, aetiology mostly viral hepatitis. Other vasoactive drug group: mean age 46 years, 71% men, aetiology mostly viral hepatitis. |
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| 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 secondarily to 12 mg/24 hours. Response defined as a reduction of serum creatinine ≥ 25% compared to baseline after every 48 hours 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 guided by a mean arterial pressure around 85 mmHg to 90 mmHg. Maximum dose 3 mg/hour. Cointervention: Both arms treated with albumin to maintain a central venous pressure between 10 cmH2O and 15 cmH2O. Dose not reported. |
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| Outcomes |
Primary outcome: reversal of hepatorenal syndrome. Secondary outcomes: 30 days survival and treatment costs. |
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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 | Egypt. | |
| Inclusion period | January 2009 to April 2012. | |
| Notes | Full paper. Participants who died within 72 hours after randomisation excluded from study. We contacted the authors, but were unable gather any further information. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description. |
| Allocation concealment (selection bias) | Unclear risk | Sealed opaque envelopes (text did not explain if envelopes were serially numbered). |
| 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 | No missing outcome data described. Participants who died within 72 hours excluded from analyses, but number allocated to 2 intervention groups not given. |
| Selective reporting (reporting bias) | Low risk | Clinically relevant outcome 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 | |