- Early initiation of renal replacement therapy in critically ill patients: a meta- analysis of randomized clinical trials. - Background: Acute kidney injury (AKI) is strongly associated with high morbidity and mortality of critically ill patients. - In the last years several different biological markers with higher sensitivity and specificity for the occurrence of renal impairment have been developed in order to promptly recognize and treat AKI. - Nonetheless, their potential role in improving patients ’ outcome remains unclear since the effectiveness of an “ earlier ” initiation of renal replacement therapy (RRT) is still debated. - Since one large, high-quality randomized clinical trial has been recently pubblished, we decided to perform a meta-analysis of all the RCTs ever performed on “ earlier ” initiation of RRT versus standard RRT in critically ill patients with AKI to evaluate its effect on major outcomes.. - earlier ” initiation of RRT versus later/standard initiation). - critically ill patients.. - Results: Ten trials randomizing 2214 patients, 1073 to earlier initiation of RRT and 1141 to later initiation were included.. - No difference in mortality of 1073) for those receiving early RRT and of 1141) for controls, p = 0.97) and survival without dependence on RRT (3.6% (34 of 931) for those receiving early RRT and 4.2% (40 of 939) for controls, p = 0.51) were observed in the overall population. - On the contrary, early initiation of RRT was associated with a significant reduction in hospital length of stay. - Conclusions: Our study suggests that early initiation of RRT in critically ill patients with AKI does not provide a clinically relevant advantage when compared with standard/late initiation.. - Keywords: Renal replacement therapy, Acute kidney injury, Mortality, Intensive care unit. - Acute kidney injury (AKI) is a major issue in the intensive care unit (ICU) and is strongly associated with high mor- bidity and mortality. - In fact, despite its potential to be re- versed, several studies performed in different clinical settings confirmed that occurrence of AKI is independently associated with in-hospital mortality and negative short- and long-term outcomes of critically ill patients [1 – 3].. - Given the possible severe implications of this condi- tion, in the last few decades researchers mainly focused their attention on the pathogenesis of AKI and on its prompt recognition, leading to the development of a series of different biological markers with higher sensi- tivity and specificity for the occurrence of renal impair- ment [5, 6]. - These markers play a fundamental role in the early diagnosis and treatment of AKI [7]. - Nonethe- less, their potential role in improving patients ’ outcome is still debated [8].. - In fact, actual indications for renal replacement ther- apy (RRT) in the ICU require the development of severe clinical manifestations of renal impairment, such as vol- ume overload unresponsive to medical therapy, hyperka- liemia or major electrolyte disturbances, acidosis or. - 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0. - Whether an “earlier” initiation of RRT might be effective in improving survival of critical ill patients af- fected by AKI is still debated. - Nearly all patients in the early-strategy group received RRT while approximately 30% of patients in the delayed-strategy group did not re- ceive RRT since they had spontaneous recovery of renal function. - The primary outcome of mortality at 90 days did not differ between patients who received early versus late initiation of RRT (58% vs. - Further- more, no benefits were seen from early initiation of RRT in secondary outcomes. - The ELAIN trial was smaller, conducted almost exclusively in postoperative AKI patients, and the difference in timing between early versus late initiation of RRT was less than 24 h. - There- fore, we decided to perform an updated meta-analysis of all the RCTs ever performed on “earlier” initiation of RRT versus standard RRT in critically ill patients to evaluate its effect on outcome of critically ill patients with AKI.. - The full PubMed search strategy aimed to include any RCTs ever performed on “earlier” initiation of RRT in critically ill patients with AKI. - The following inclusion criteria were used for potentially relevant studies: studies performed on critically ill pa- tients. - random allocation to treatment (“earlier” initi- ation of RRT versus later/standard initiation). - The exclusion criteria were non-adult patients, duplicate publications and lack of data on all of the following:. - The co-primary end- points of the present review were mortality at the longest follow-up available and survival with dependence on RRT.. - Subanaly- sis were performed on the subgroup of patients who underwent cardiac surgery and on general ICU patients.. - The internal validity and risk of bias of included trials was appraised by two independent reviewers according to the latest version of the “Risk of bias assessment tool”. - 2015 Post – cardiac surgery shock. - 2013 Patients With. - Payen D Crit Care Med. - Mean time to initiation of RRT not specified. - The 10 included trials randomized 2214 patients, 1073 to earlier initiation of RRT and 1141 to later initiation.. - (Table 1) Clinical heterogeneity was mostly due to set- ting and criteria for early and late initiation of RRT.. - Overall analysis showed that early initiation of RRT does not improve outcome of critically ill patients with AKI. - 3) Results were confirmed at sensitivity analyses and the funnel plot illustrated in the Additional file 1. - On the contrary, early initiation of RRT was associated with a significant reduction in HLOS. - Our meta-analyses suggests that early initiation of RRT does not improve clinically relevant outcomes of critic- ally ill patients with AKI. - Moreover, although we found an overall significant reduction in HLOS in the subgroup of patients who received early RRT, these positive results were not confirmed in the high-quality studies. - In addition, we didn’t find a subgroup of patients in which early initiation of RRT could me more beneficial since Table 2 Primary and secondary outcomes, adverse events and sensitivity analyses. - Cardiac surgery patients to . - -Survival with dependence on RRT to . - RRT renal replacement therapy, OR relative risk, MD mean difference, CI confidence interval, P p-value, ICU intensive care unit, HLOS hospital length of stay. - outcome did not improve both in cardiac surgery pa- tients and general ICU patients.. - Our results diverge from the results of recent meta-analyses on this topic, while confirm the results of the less recent meta-analyses performed by Wierstra et al. - were weaker since were based on fewer, lower quality studies and didn’t include the most recent, high-quality trials published in the last year. - in our meta-analysis) and allowing to have more robust data. - Our results are consistent with the results of an- other recent meta-analyses performed by Feng et al.. - Moreover they did not per- form any subanalyses on general ICU patients or cardiac surgery patients, therefore drawing weaker conclusions.. - On the contrary, Moreira et al. - Although our meta-analysis includes all the random- ized clinical trials ever published on early vs late RRT and two large, recent, high-quality RCTs, the optimal timing of initiating RRT remains unclear. - In fact, in the last decade the Kid- ney Disease Improving Global Outcomes (KDIGO) Clin- ical Practice Guideline contributed to standardize AKI treatment. - Initiation of RRT, to some extent, depends on creatinine level and urine output, namely, the KDIGO criteria. - Therefore, one of the main limitations of our meta-analysis and of all the performed and ongoing trials is the lack of definition of. - “early” versus “late” criteria, that varied among the in- cluded studies and may have led to great differences in the requirements for RRT and their therapeutic impact.. - Actually, there is another on- going RCT that will probably provide additional infor- mations on the optimal timing of starting RRT in critically ill patients admitted to general ICU (STARR- T-AKI, NCT02568722). - Unfortunately, given the previ- ous reported limitations, this trial will not probably allow to draw definitive conclusions on the optimal tim- ing of starting RRT in critically ill patients.. - Our meta-analysis supports the notion that early initi- ation of RRT in critically ill patients with AKI does not provide a clinically relevant advantage when compared with standard/late initiation. - Based on the limitations of the data available for. - our analysis, future work in the following areas is desir- able: (1) stardardized definition of “early” and “late” initi- ation of RRT. - (3) an as- sessment of the performance of the different RRT mo- dalities and dosage options.. - AKI: Acute kidney injury. - RRT: Renal replacement therapy. - LP conception and design of the work. - Laura Pasin is a member of the editorial board of this journal. - 3 Forest plot for survival with dependence on RRT. - Beijing acute kidney injury trial (BAKIT) workgroup. - A comparison of different diagnostic criteria of acute kidney injury in critically ill patients. - Crit Care. - Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study.. - Intensive Care Med. - Prognosis for long-term survival and renal recovery in critically ill patients with severe acute renal failure: a population-based study. - The predictive value of early acute kidney injury for long-term survival and quality of life of critically ill patients. - 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