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2017年05月31日 研究点评, 进展交流 暂无评论

Recommended Reading from the University of Ottawa Nephrology Fellows

David Massicotte-Azarniouch, Syed Obaid Amin, Caitlin Hesketh and Edward G. Clark

AJRCCM Articles in Press. Published on 02-May-2017 as 10.1164/rccm.201611-2375RR

Zarbock et al. Effect of Early vs Delayed Initiation of Renal Replacement Therapy on Mortality in Critically Ill Patients With Acute Kidney Injury: The ELAIN Randomized Clinical Trial. JAMA (6)

Reviewed by Syed Obaid Amin

The Effect of Early vs Delayed Initiation of Renal Replacement Therapy on Mortality in Critically Ill Patients With Acute Kidney Injury (ELAIN) study (6) is another, recently published RCT addressing the issue of whether ‘early’ vs ‘delayed’ RRT initiation for AKI is preferable in critically ill patients.

ELAIN was an open-label, single-center study that included 231 critically ill patients with evidence of acute renal tubular damage (as per the presence of a blood neutrophil gelatinase-associated lipocalin (NGAL) level of ≥ 150 ng/mL), KDIGO stage 2 AKI (a 2-fold increase in serum creatinine from baseline or urine output < 0.5 ml/kg/hr for 12 hours) and one or more of the following: sepsis, catecholamine dependence, hypoxemia, fluid overload, or progressive non-renal organ injury. Those randomized to the ‘early’ group received RRT within 8 hours (median (IQR) of 6.0 (4.0 – 7.0) hours after meeting eligibility requirements) while the ‘delayed’ group were initiated either within 12 hours of reaching KDIGO stage 3 AKI (serum creatinine ≥ 3 times baseline or ≥ 4 mg/dl, and/or urine output < 0.3 ml per kilogram for ≥ 24 hours or anuria for ≥ 12 hours) or if an absolute indication for RRT occurred (median (IQR) of 25.5 (18.8 – 40.3) hours after meeting eligibility requirements).

Almost all patients included in the study were admitted post-operatively (over half of them following cardiac surgery). Baseline characteristics, NGAL levels and indications for initiation of RRT were not significantly different between ‘early’ and ‘delayed’ groups. The ‘early’ group was found to have significantly lower 90 day all-cause mortality (the primary endpoint) than the ‘delayed’ group (39.3% vs 54.7%, respectively; P = 0.03) with no significant difference in 28 day and 60 day all-cause mortality, length of ICU stay, and RRT requirement at day 90 between the groups. The ‘early’ group was found to have a significantly shorter duration on RRT, shorter hospitalization and less time on mechanical ventilation. No patients were lost to follow up. In both AKIKI and ELAIN, all patients randomized to ‘early’ groups received RRT (1, 6). While in AKIKI, almost half of patients randomized to ‘delayed’ RRT did not receive it (mainly because they recovered kidney function prior to developing an acute indication for RRT) less than 10% in the ‘delayed’ arm in ELAIN did not receive RRT. This is because the trigger for initiation of RRT in the ‘delayed’ arm of ELAIN was based on reaching criteria for KDIGO stage 3 AKI rather than the presence of absolute indications for RRT alone.

It is notable that, relative to AKIKI, patients in the ELAIN study had higher severity of illness scores (mean SOFA score 16 vs 11) and were more likely to have chronic kidney disease. One issue is that ELAIN may have limited generalizability given that it was a single-center study and almost entirely surgical admissions (in contrast to AKIKI in which most admissions were medical (1)). Another potential limitation, highlighted by the authors, is that single-center studies are prone to inflated effect sizes (7). Similarly, some experts have commented that, although the mortality benefit was statistically significant, it was not robust: a change in outcome for a very small number of patients would have resulted a non-significant difference (5).

As such, the conflicting AKIKI and ELAIN studies provide more information regarding the optimal timing of initiation of RRT for AKI but do not provide compelling evidence for clinicians to alter their current practices. Their differing findings may relate to differences in the patient populations they assessed as well as study design (in particular, different triggers for inclusion and RRT initiation). Two ongoing, large RCTs (IDEAL-ICU (8) and STARRT-AKI (9)) will hopefully provide more definitive evidence with which to guide practice.

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