AKIKI trial [23] | ELAIN trial [24] | |
---|---|---|
Study design | Multicenter (31 ICUs in France): randomized, unblinded | Single center (one ICU in Germany): randomized, unblinded |
Patient characteristics and number | Predominantly medical patients (79%); n = 620 (from 5528 screened patients (11%)) | Predominantly postsurgical patients (97%); n = 231 (from 604 screened patients (38%)) |
Age at enrollment (years) | 66.1a | 67.0a |
SOFA score at enrollment | 10.9a | 15.8a |
Septic shock at enrollment (%) | 66.7 | 32.0 |
Enrollment criteria | ICU patients, ≧18 years old; KDIGO stage 3 AKI; at least one of the following: MV, catecholamine need | ICU patients, 18–90 years old; KDIGO stage 2 AKI; plasma NGAL > 150 ng/ml; at least one of the following: severe sepsis, catecholamine need, nonrenal organ dysfunction, fluid overload |
Criteria for RRT in EG | KDIGO stage 3 AKI (within 6 h) | KDIGO stage 2 AKI (within 8 h) |
Criteria for RRT in DG | Any of the following: BUN > 112 mg/dl, sK > 6 mEq/L, pH < 7.15, lung edema, oliguria > 72 h | KDIGO stage 3 AKI or any of the following (within 12 h): BUN > 100 mg/dl, sK > 6 mEq/L, sMg > 8 mEq/L, organ edema, U/O < 200 ml/h |
SCr at RRT (mg/dl) | 3.3 (EG) vs 5.3 (DG)a | 1.9 (EG) vs 2.4 (DG)a |
Time to RRT (h) | 2.0 (EG) vs 57.0 (DG)b, c | 6.0 (EG) vs 25.5(DG)b, d |
Initial modality | 55.0% IHD, 45.0% CRRT (modality not available) | 100.0% CRRT (CVVHDF) |
Receipt of RRT | EG (98.0%) > DG (51.0%) (p < 0.001) | EG (100.0%) > DG (91.0%) (p < 0.001) |
Primary endpoint | 60-day mortality EG (48.5%) ≒ DG (49.7%) (p = 0.79) | 90-day mortality EG (39.3%) < DG (54.7%) (p = 0.03) → EG better |
Other outcomes | Catheter-related-infection: EG (10.0%) > DG (5.0%) (p = 0.03) → DG better | Median LOS: EG (51 days) < DG (82 days) (p < 0.001) Duration of MV: EG (126 h) < DG (181 h) (p = 0.002) → EG better |
Special remarks | 60-day mortality: all EG (48.5%) ≒ DG (49.7%); DG/RRT(–) (37.1%) < EG (48.5%) < DG/RRT(+) (61.8%) |