Introduction
Materials and methods
Patients and ethics
MARS® therapy applications
Endpoints
Statistical analysis
Results
MARS® therapy applications
Group description
Overall (n = 158) | Acute-on-chronic liver failure (n = 54) | Acute liver failure (n = 32) | Post-surgery liver failure (n = 25) | Refractory pruritus (n = 35) | Drug intoxication (n = 12) | |
---|---|---|---|---|---|---|
Demographics | ||||||
Age (years) | 54 [43–64] | 56 [39–65] | 58 [39–65] | 58 [46–67] | 48 [40–54] | 51 [36–57] |
Male gender (n) | 99 (62.7) | 41 (75.9) | 18 (56.3) | 19 (76.0) | 13 (37.1) | 8 (66.7) |
BMI (kg/m2) | 25 [21–28] | 25 [21–29] | 26 [23–29] | 28 [22–29] | 22 [19–24] | 23 [20–25] |
Severity of illness | ||||||
SOFA score | 8 [4–10] | 9 [7–10] | 8 [6–11] | 8 [10–12] | 3 [1–4] | 11 [8–15] |
Respiratory | 0 [0–1] | 0 [0–1] | 1 [0–1] | 1 [0–3] | 0 [0–0] | 2 [1, 2] |
Cardiovascular | 0 [0–0] | 0 [0–0] | 0 [0–3] | 3 [0–4] | 0 [0–0] | 2 [0–4] |
Hepatic | 3 [2–4] | 4 [4] | 3 [2–4] | 4 [2–4] | 2 [0–3] | 0 [0–2] |
Coagulation | 1 [0–2] | 2 [1, 2] | 1 [0–2] | 2 [1, 2] | 0 [0–1] | 1 [0–2] |
Neurologic | 0 [0–1] | 0 [0–2] | 0 [0–3] | 0 [0–2] | 0 [0–0] | 4 [4] |
Renal | 1 [0–2] | 2 [1–3] | 1 [0–4] | 1 [0–1] | 0 [0–0] | 2 [1, 2] |
Catecholamines (n) | 48 (30.4) | 18 (33.3) | 9 (28.1) | 15 (60.0) | 0 (0.0) | 6 (50.0) |
Child Pugh score | NA | 11 [10–12] | NA | NA | NA | NA |
MELD score | NA | 34 [28–39] | 28 [22–39] | NA | NA | NA |
Acute-on-chronic liver failure
Acute liver failure
Post-surgery liver failure
Refractory pruritus
Drug intoxication
Main endpoint: adverse events
Overall | Acute-on-chronic liver failure | Acute liver failure | Post-surgery liver failure | Refractory pruritus | Drug intoxication | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Admissions | Sessions | Admissions | Sessions | Admissions | Sessions | Admissions | Sessions | Admissions | Sessions | Admissions | Sessions | |
n = 180 | n = 513 | n = 56 | n = 165 | n = 32 | n = 99 | n = 28 | n = 71 | n = 52 | n = 149 | n = 12 | n = 29 | |
Cannula-related complications | ||||||||||||
Culture proven infection of cannula | 3(1.7) | 3(0.6) | 3(5.4) | 3(1.8) | 0(0) | 0(0) | 0(0) | 0(0) | 0(0) | 0(0) | 0(0) | 0(0) |
Cannula site bleeding | 10(5.6) | 10(1.9) | 6(10.7) | 6(3.6) | 0(0) | 0(0) | 2(7.1) | 2(2.8) | 2(3.8) | 2(1.3) | 0(0) | 0(0) |
Cannula dysfunction | 5(2.8) | 5(1.0) | 1(1.8) | 1(0.6) | 0(0) | 0(0) | 0(0) | 0(0) | 4(7.7) | 4(2.7) | 0(0) | 0(0) |
Cardiac arrhythmia related to cannula insertion | 2(1.1) | 2(0.4) | 1(1.8) | 1(0.6) | 0(0) | 0(0) | 0(0) | 0(0) | 1(1.9) | 1(0.7) | 0(0) | 0(0) |
Circuit-related complications | ||||||||||||
Coagulation of the circuit or membrane | 36(20.0) | 42(8.2) | 13(23.2) | 15(9.1) | 8(25.0) | 10(10.1) | 4(14.3) | 4(5.6) | 8(15.4) | 10(6.7) | 3(25.0) | 3(10.3) |
Hypothermia | 34(18.9) | 34(6.6) | 15(26.8) | 15(9.1) | 3(9.4) | 3(3.0) | 9(32.1) | 9(12.7) | 5(9.6) | 5(3.3) | 2(16.7) | 2(6.9) |
Arterial hypotension | 21(11.7) | 26(5.1) | 7(12.5) | 9(5.5) | 3(9.4) | 6(6.1) | 5(17.9) | 5(7.0) | 4(7.7) | 4(2.7) | 2(16.7) | 2(6.9) |
Thrombocytopenia associated to MARS® | ||||||||||||
Preemptive platelets transfusion | 30(16.7) | 36(7.0) | 15(26.8) | 19(11.5) | 5(15.2) | 6(6.1) | 9(32.1) | 10(14.1) | 1(1.9) | 1(0.7) | 0(0) | 0(0) |
MARS®-associated thrombocytopenia | 55(30.6) | 65(12.7) | 20(35.7) | 25(15.2) | 13(40.6) | 14(14.1) | 10(35.7) | 12(16.9) | 8(15.4) | 9(6.0) | 4(33.3) | 5(17.2) |
Neurologic events | ||||||||||||
Epileptic seizure | 3(1.7) | 3(0.6) | 1(1.8) | 1(0.6) | 1(3.1) | 1(1.0) | 1(3.6) | 1(1.4) | 0(0) | 0(0) | 0(0) | 0(0) |
CNS hemorrhage | 1(0.6) | 1(0.2) | 0(0) | 0(0) | 1(1.0) | 1(1.0) | 0(0) | 0(0) | 0(0) | 0(0) | 0(0) | 0(0) |
Secondary endpoints: clinical and biological effects
Acute-on-chronic liver failure | Acute liver failure | Post-surgery liver failure | Refractory pruritus | Drug intoxication | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(n = 56) | (n = 32) | (n = 28) | (n = 52) | (n = 12) | |||||||||||
Before MARS® | After MARS® | p value | Before MARS® | After MARS® | p value | Before MARS® | After MARS® | p value | Before MARS® | After MARS® | p value | Before MARS® | After MARS® | p value | |
Total bilirubin (µmol/L) | 505 [311–642] | 349 [228–403] | < 0.01 | 341 [188–520] | 268 [109–353] | < 0.01 | 479 [337–551] | 287 [176–347] | < 0.01 | 82 [27–185] | 62 [23–142] | < 0.01 | 20 [11–112] | 15 [11–61] | 0.01 |
ALT (IU/L) | 56 [34–117] | 76 [43–175] | 0.06 | 440 [121–1705] | 250 [94–650] | < 0.01 | 153 [81–241] | 100 [60–150] | 0.02 | 71 [43–90] | 50 [33–94] | 0.07 | 96 [33–202] | 88 [21–130] | 0.67 |
AST (IU/L) | 102 [63–173] | 128 [62–209] | 0.03 | 259 [124–696] | 116 [82–234] | 0.02 | 100 [61–174] | 72 [50–101] | 0.04 | 73 [55–120] | 67 [49–110] | 0.07 | 60 [36–102] | 49 [24–148] | 0.72 |
GGT (IU/L) | 67 [35–205] | 92 [33–232] | 0.45 | 131 [41–314] | 115 [56–307] | 0.48 | 143 [81–260] | 134 [93–297] | 0.96 | 155 [89–421] | 148 [68–385] | < 0.01 | 165 [69–253] | 152 [48–242] | 0.72 |
Prothrombin time (%) | 42 [30–51] | 47 [38–68] | < 0.01 | 39 [19–52] | 60 [39–74] | < 0.01 | 61 [48–73] | 63 [52–75] | 0.56 | 90 [72–100] | 82 [70–100] | 0.64 | 78 [65–83] | 78 [56–87] | 0.76 |
Albumin (g/L) | 33 [28–36] | 31 [28–34] | 0.20 | 30 [27–31] | 31 [27–34] | 0.12 | 30 [26–35] | 30 [25–32] | 0.34 | 33 [29–35] | 33 [28–35] | 0.11 | 28 [26–30] | 29 [26–30] | 0.96 |
Hemoglobin (g/dL) | 9.0 [8.2–9.9] | 9.4 [8.0–10.2] | 0.83 | 10.7 [9.6–12.4] | 9.5 [8.6–10.6] | < 0.01 | 9.2 [8.6–10.2] | 9.2 [8.2–8.6] | 0.14 | 11.0 [9.7–11.8] | 9.6 [9.0–10.6] | < 0.01 | 9.2 [8.7–11.0] | 9.3 [8.8–9.7] | 0.13 |
Platelets count (× 109/L) | 80 [57–116] | 72 [54–101] | 0.01 | 97 [70–159] | 94 [66–132] | 0.19 | 92 [63–104] | 77 [53–88] | 0.15 | 167 [106–236] | 116 [75–168] | < 0.01 | 116 [75–186] | 163 [91–246] | 0.97 |
Blood lactate concentration (mmol/L) | 1.6 [1.2–2.1] | 1.4 [1.0–1.8] | 0.13 | 2.3 [1.7–2.8] | 1.6 [1.2–2.5] | 0.01 | 1.5 [1.2–2.2] | 1.2 [1.3–1.8] | 0.45 | 0.9 [0.7–1.4] | 1.0 [0.9–1.4] | 0.51 | 1.6 [1.2–2.3] | 1.5 [1.0–1.9] | 0.47 |
Glasgow coma scale score | 14 [7–15] | 15 [14, 15] | 0.01 | 13 [4–15] | 15 [11–15] | 0.09 | 15 [9–15] | 15 [9–15] | 0.90 | 15 [15] | 15 [15] | 0.99 | 4 [3, 4] | 15 [14, 15] | 0.01 |
Encephalopathy (West Haven criteria) | 2 [0–4] | 1 [0–3] | 0.01 | 2 [0–4] | 0 [0–2] | 0.01 | 1 [0–4] | 1 [0–4] | 0.99 | 0 [0–0] | 0 [0–0] | 0.99 | NA | NA |