Gastroenterology in critical care · Hepatorenal syndrome
Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome
| Design | Phase 3 multicentre randomised, placebo-controlled trial |
|---|---|
| Treatment | Terlipressin plus albumin |
| Control | Placebo plus albumin |
| Population | 300 adults with cirrhosis and type 1 hepatorenal syndrome: 199 terlipressin and 101 placebo |
| Follow-up | 90 days |
| Primary endpoint | Verified reversal of hepatorenal syndrome |
| Result | Verified reversal of hepatorenal syndrome occurred in 63 of 199 (32%) with terlipressin versus 17 of 101 (17%) with placebo (p=0.006). Death within 90 days due to respiratory disorders occurred in 22 (11%) versus 2 (2%). All-cause death at 90 days was numerically higher with terlipressin, 101 (51%) versus 45 (45%). |
| Secondary endpoints | HRS reversal, HRS reversal without renal-replacement therapy by day 30, HRS reversal in patients with SIRS, verified reversal without recurrence by day 30 |
In this trial involving adults with cirrhosis and HRS-1, terlipressin was more effective than placebo in improving renal function but was associated with serious adverse events, including respiratory failure.
The trial authors, in the published abstract
The respiratory failure signal is why this trial belongs on a respiratory site: terlipressin improves the kidney and can drown the patient. Death from respiratory disorders was 11% versus 2%, and all-cause 90-day mortality was numerically higher on treatment. Volume status and pulmonary reserve now govern who is offered it.
Wong F, Pappas SC, Curry MP, et al. Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome. N Engl J Med 2021 Mar 4;384(9):818-828.