Table 1.
Baseline characteristics of the BETA trial by treatment group.
| Placebo Group | Albumin Group | |
|---|---|---|
| n = 42 | n = 40 | |
| Male, n (%) | 26(61.9) | 29(72.5) |
| Age, median (IQR) | 69.1(63.3–75.3) | 66.5(59.9–73.6) |
| BMI, median (IQR) | 24.5(23.2–26.5) | 24.2(23.2–26.8) |
| Etiology, n (%) | ||
| Alcohol related | 22(57.7) | 19(47.5) |
| MAFLD | 2(4.9) | 4(10) |
| Alcohol and HCV | 4(9.8) | 6(15) |
| HCV | 5(12.2) | 6(15) |
| Alcohol and MAFL | 2(4.9) | -- |
| Other * | 7(8.8) | 5(6.1) |
| Previous decompensations, n (%) | ||
| Ascites | 35(83.3) | 30(75) |
| Hepatic encephalopathy | 27(64.3) | 26(65) |
| Spontaneous bacterial peritonitis | 7(16.7) | 7(17.5) |
| Gastrointestinal bleeding | 11(26.2) | 11(27.6) |
| Hepatorenal syndrome | 2(4.8) | 3(7.5) |
| Hepatocellular carcinoma | 5(11.9) | 4(10) |
| Other comorbidities, n (%) | ||
| Hypertension | 26(66.7) | 23(59) |
| Dyslipidemia | 9(23.1) | 7(17.9) |
| Diabetes | 20(51.3) | 14(35.9) |
| Severity score, median (IQR) | ||
| MELD | 17(16–20) | 17(15–20) |
| Treatment at inclusion, n (%) | ||
| Rifaximin and/or lactulose | 35(83.3) | 31(77.5) |
| Laboratory parameters, median (IQR) | ||
| Hemoglobin g/dL | 10.6(9.9–13) | 10.9(9.3–11.8) |
| Leukocytes x109/L | 5.06(3.8–7.4) | 5.09(4.06–6.6) |
| Platelets x10E9/L | 82.5(64–109) | 76.5(57.5–106.5) |
| Sodium mEq/L | 135.8(132.8–138.6) | 136.2(134–139) |
| AST IU/L | 44(31–64) | 51(36–75) |
| ALT IU/L | 26(18–35) | 32.5(22–43.5) |
| Bilirubin mg/dL | 3.2(1.7–4.6) | 2.97(1.91–5) |
| Albumin g/dL | 2.85(2.35–3.01) | 2.6(2.41–2.93) |
| INR | 1.53(1.37–1.71) | 1.55(1.35–1.83) |
| Creatinine (mg/dL) | 1.08(0.77–1.53) | 0.99(0.7–1.32) |
| Mean Arterial Pressure (mmHg) | 82.6(76–94.3) | 78.7(72.5–89.3) |
| Current liver-related decompensations, n (%) ♦ | ||
| Ascites | 19(45.2) | 17(42.5) |
| Hepatorenal syndrome | 1(2.4) | -- |
| Precipitant factors, n (%) | ||
| Infection | 11(26.1) | 12(30) |
| Constipation | 9(21.4) | 9(22.5) |
| Dehydration | 4(9.5) | 3(7.5) |
| Diuretics | 14(33.3) | 23(59) ** |
| West Haven at screening, n (%) | ||
| II | 30(71.4) | 31(77.5) |
| III | 11(26.2) | 9(22.5) |
| IV | 1(2.4) | -- |
| CHESS scale | 2.5 (1–6) | 2(1–4) |
* Other etiologies included hepatitis B and delta virus, primary biliary cholangitis, primary sclerosing cholangitis, secondary cholangitis, cryptogenic, Wilson’s disease, and autoimmune hepatitis. ** p = 0.02. ♦ Ascites did not require large-volume paracentesis and albumin infusion at the time of inclusion, and HRS was diagnosed within hours following inclusion. Body mass index, BMI; metabolic-associated fatty liver disease, MAFLD; hepatitis C virus, HCV; MELD model of end-stage liver disease, MELD; aspartat aminotrasferase, AST; alanine aminotransferase, ALT; hepatic encephalopathy, HE; clinical hepatic encephalopathy staging scale, CHESS.