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© SICS EBM Group 2004
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Terlipressin in hepatorenal syndrome
Citation/s:
Solanki P. Chawla A. Garg R. Gupta R. Jain M. Sarin SK. Beneficial effects of
terlipressin in hepatorenal syndrome: a prospective, randomized
placebo-controlled clinical trial. Journal of Gastroenterology & Hepatology.
18(2):152-6, 2003 Feb.
Three-part Clinical Question: Patients: Decompensated cirrhosis with hepatorenal syndrome. Intervention: Terlipressin Outcomes: Mortality
The Study: Single-blinded randomised controlled trial with intention-to-treat.
The Evidence:
EBM questions:
1. Do the methods allow accurate testing of the hypothesis? Yes
2. Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes – although published as SEM and not SD
3. Are conclusions valid in light of the results? Yes
4. Did results get omitted, and why? No – all accounted for.
5. Did they suggest areas of further research? Yes – stated that larger trials with higher doses of terlipressin, or longer courses, may warrant further investigation.
6. Did they make any recommendations based on the results and were they appropriate? No, authors state that their practice also involved the administration of Albumin and the combination is ‘quite beneficial’
7. Is the study relevant to my clinical practice? Yes. Intensive care is a common place to find patients with decompensated liver disease and progression to hepatorenal syndrome is common, although, when accessing applicability to your own patient population one must consider the following: (i) The population group is less ill than most UK ICUs are used to (no reported ventilatory support required, 4 hourly obs, bloods every 2 days). It should not be assumed that the results from a small single blind study apply to more seriously ill patients, especially given effects of ventilation (ii)This study had some variations from what we might consider standard practice, all patients receive ‘vasodilatory’ doses of dopamine for 1 – 2days and all had daily albumin (20g) with FFP given to ensure CVP was above 10cmH2O. They also mention that tense ascites was drained by large volume paracentesis with additional albumin replacement but fail to record how often and in whom it was required.
8. What level of evidence does this study represent? 1+ (RCT with low risk of bias)
9. What grade of recommendation can I make on this result alone? Grade B
10. What grade of recommendation can I make when this study is considered along with other available evidence? Unaware of similar studies of decent quality
11. Should I change my practice because of these results? Perhaps – the patient population group is different but current practice is often to offer these patients no therapeutic option at all with a resultant 100% mortality. Some survivors deteriorated (? Died) after end of study, so true benefit uncertain.
12. Should I audit my current practice because of these results? Yes
Appraised by Dr Ewan Jack, Spr, Glasgow
Email: ewanwendy@supanet.com
Kill or update by 2010
Reviewed & Edited by CC & SJM
Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. 2006. Jack E. Solanki P. Chawla A. Garg R. Gupta R. Jain M. Sarin SK. Beneficial effects of terlipressin in hepatorenal syndrome: a prospective, randomized placebo-controlled clinical trial. Journal of Gastroenterology & Hepatology. 18(2):152-6, 2003.
©SICS EBM 2006
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