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Description : Artificial Kidney Initiation for Kidney Injury 2

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Published on : Feb 23, 2022 | Views : 1755 | Downloads : 6

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Original Article Comparison of two delayed strategies for renal replacement therapy initiation for severe acute kidney injury (AKIKI 2) f1 Kritsada Pongsakornkullachart, MD Division of nephrology Department of medicine, siriraj hospital 31 august 2021
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Outline Introduction Methods Study design Procedures Outcomes Statistical analysis Results Discussion Critical appraisal
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introduction
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AKIKI trial N Engl J Med 2016;375:122-33. RCT, multicenter (31 ICU in France) N = 619, F/U 60 days September 2013 - January 2016 P Patients > 18 years who admitted to ICU with AKI stage 3 and receiving invasive mechanical ventilation, catecholamine infusion or both I Early RRT (N = 311) C Delayed RRT (N = 308) O Primary endpoint was overall survival at day 60 Early RRT was started immediately after randomization Delayed RRT was initiated if at least one of the following criteria (severe hyperkalemia, metabolic acidosis, pulmonary edema, BUN > 112 mg/dL, or oliguria > 72 hours after randomization
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AKIKI trial N Engl J Med 2016;375:122-33.
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IDEAL-ICU trial N Engl J Med 2018;379:1431-42. RCT, multicenter (29 ICU in France) N = 488, F/U 180 days July 2012 – October 2016 P Patients > 18 years admitted to the ICU in the early phase of septic shock (within 48 hours after the start of vasopressor therapy), and AKI with at least one of the following criteria for the failure stage of the RIFLE I Early strategy of RRT (N = 246) C Late strategy of RRT (N = 242) O Primary endpoint was death from any cause at 90 days Early strategy initiated within 12 hours Late strategy any one of the following (K >6.5 mmol/L, pH <7.15 or fluid overload and refractory to diuretics)
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IDEAL-ICU trial N Engl J Med 2018;379:1431-42.
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STARRT-AKI trial N Engl J Med 2020;383:240-51. RCT, multinational (168 hospitals in 15 countries) N = 2,927, F/U 90 days October 2015 - September 2019 P Patients > 18 years admitted to an ICU with severe AKI (KDIGO stage 2 or 3) I Accelerated strategy of RRT (N = 1,465) C Standard strategy of RRT (N = 1,462) O Primary endpoint was death at 90 days Accelerated strategy initiated within 12 hours Standard strategy conventional indications developed (K > 6 mmol/L, pH < 7.20 or serum HCO3 <12 mmol/L, volume overload) or persistent AKI > 72 hours after randomization
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STARRT-AKI trial N Engl J Med 2020;383:240-51.
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Systematic review and individual patient data meta-analysis, 9 studies Published from April 1, 2008, to Dec 20, 2019 1,879 patients had severe AKI Compared delayed and early RRT initiation strategies 946 (50%) to the delayed RRT group and 933 (50%) to the early RRT group 390 (42%) of 929 patients allocated to the delayed RRT group and who had available data did not receive RRT The proportion of patients who died by day 28 did not significantly differ between the delayed RRT group (366 [44%] of 837) and the early RRT group (355 [43%] of 827; risk ratio 1·01 [95% CI 0·91 to 1·13], p=0·80), corresponding to an overall risk difference of 0·01 (95% CI –0·04 to 0·06)
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STARRT-AKI trial N Engl J Med 2020;383:240-51.
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AKIKI 2 trial
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methods
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Study design Multicentre (39 ICU in France) RCT, two-arm Unmasked Open-label
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Participants (Inclusion criteria) 1. Aged ≥ 18 years 2. Hospitalised in the ICU 3. Receiving invasive mechanical ventilation or catecholamine infusion, or both 4. AKI stage 3 (KDIGO)
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Participants (Inclusion criteria) 1. Aged ≥ 18 years 2. Hospitalised in the ICU 3. Receiving invasive mechanical ventilation or catecholamine infusion, or both 4. AKI stage 3 (KDIGO)
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Participants (Exclusion criteria) 1. Urgent indications for immediate RRT
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Participants (Exclusion criteria) 1. Urgent indications for immediate RRT 2. BUN > 140 mg/dL 3. Severe chronic renal failure (CrCl < 30 ml/min) 4. Present > 24 hours (to avoid delayed inclusions) 5. AKI caused by Urinary tract obstruction Renal vessel obstruction Tumour lysis syndrome Thrombotic microangiopathy Acute glomerulopathy 6. Poisoning by a dialyzable agent
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Participants (Exclusion criteria) 7. Child C liver cirrhosis 8. Cardiac arrest without awakening 9. Moribund state (patient likely to die within 24h) 10. Patient having already received RRT for the current episode of AKI 11. Renal transplant 12. Treatment limitation (withholding or withdrawal) 13. Previous inclusion in this study 14. Subject deprived of freedom 15. Subject under a legal protective measure 16. Pregnant or breastfeeding woman
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Randomisation and masking Computer-generated, balanced by blocks of variable and undisclosed size, and stratified per centre Randomly assigned in a 1:1 ratio (delayed : more-delayed RRT) Allocation concealment was achieved by means of a centralised, secure, interactive, web-response system accessible from each study centre (Cleanweb, Telemedecine Technologies SAS, Boulogne-Billancourt, France)
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Procedures
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Procedures Delayed strategy arm RRT initiated within 12 h after fulfilling the randomisation
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Procedures More-delayed strategy arm RRT was postponed until one urgent indication occurred or BUN > 140 mg/dL (> 50 mmol/L) for one day Duration of anuria was not a criterion for initiation The decision to initiate RRT had to be approved by the attending physician involved in the patient’s care
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Procedures
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Procedures Management of RRT (including choice of intermittent or continuous technique, duration and interval between sessions, device setting, or anticoagulation modality) was left to the discretion of each study site and was prescribed and monitored according to national guidelines In both groups, RRT discontinuation was contemplated if Spontaneous diuresis > 500 mL/24 h Spontaneous diuresis > 1,000 mL/24 h (highly recommened) Diuresis > 2,000 mL/24 h in patients receiving diuretics Diuresis was sufficient to allow for spontaneous serum creatinine concentration decrease (mandatory)
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Procedures If improvement of renal function was insufficient to achieve a spontaneous decrease in creatinine concentration or if diuresis became lower than 1,000 mL/24 h without diuretics (or lower than 2,000 mL/24 h under diuretics), or both, RRT was resumed The duration of follow-up was 60 days
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outcomes
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Primary outcome RRT-free days between randomisation and day 28
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Secondary outcome Vital status at ICU and hospital discharge, at day 28 and 60 Percentage of patients receiving RRT at least once Number of RRT sessions between randomisation and day 28 Time between inclusion in the observational stage and RRT initiation Number of patients with renal function recovery between randomisation and day 60 Number of ventilator-free and catecholamines-free days between randomisation and day 28 Duration from randomisation and both ICU and hospital discharge Reason for initiation of RRT, its modalities and duration Number of dialysis catheter-free days between randomisation and day 28
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Secondary outcome Rate of catheter-related bloodstream infection Barthel Activities Daily Living Index at day 60 Complications potentially related to acute kidney injury or RRT Number of patients with treatment limitation Hydration and nutritional status
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Outcome Post-hoc analysis primary outcome and mortality at day 60 as a function of the criterion that mandated randomisation [oliguria or anuria > 72 h or BUN > 112 mg/dL (40 mmol/L)]
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Statistical analysis
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Statistical analysis Mean number of RRT-free days at day 28 in the delayed strategy was expected to be 17 days (from AKIKI trial) More-delayed strategy would increase this parameter to 21 days (an increase of 4 days—ie, approximately 25%) Drop-out rate of approximately 5% Total sample size required was 270 (135 in each group) to detect this difference with 80% power (α=5%, bilateral formulation)
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Statistical analysis Checked normality of distribution of the primary endpoint by means of a Shapiro- Wilk test RRT-free days were described by means of median (IQR; 25th percentile to 75th percentile) and compared between the two groups by means of a non-parametric Wilcoxon rank-sum test Categorical endpoints were compared by χ-squared or Fisher’s exact test Continuous endpoints were compared by Student’s t or Wilcoxon test
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Statistical analysis To assess the prognostic factors potentially involved in 60-day mortality and to improve the estimation accuracy of the RRT initiation strategy effect on 60-day mortality, prespecified analysis with a multivariable Cox regression model Hazard ratio (95% CI) was reported for each prognostic factor
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fundings
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Fundings Funded by French Ministry of Health
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results
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Results 7 May 2018 – 11 October 2019 5,336 patients assessed 278 patients with KDIGIO stage 3 AKI underwent randomization
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Results Among 757 eligible patients with KDIGO stage 3 AKI, 127 patients (0.17%) received RRT without being randomly assigned because of urgent indication Median time between KDIGO stage 3 AKI and RRT initiation was 35 hr (IQR 17– 68) in these 127 patients
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Primary outcome
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Risk factors for day-60 mortality
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Post-hoc analysis
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COMPLICATIONS POTENTIALLY RELATED TO AKI OR RRT: DEFINITIONS Hemorrhage was defined as requirement for red blood cell transfusion Thrombocytopenia : platelet < 100,000/mm3 Thrombosis of a large venous axis was diagnosed by Doppler ultrasonography Hypokalemia : potassium < 3 mmol/liter Hypophosphatemia : phosphate < 0.6 mmol/liter Hyperkalemia : potassium > 6.5 mmol/liter. Severe cardiac rhythm disorders included ventricular tachycardia, ventricular fibrillation and torsade de pointe Moderate cardiac rhythm disorders were defined as a new onset of atrial fibrillation requiring medical treatment or external electric counter shock
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Biological characteristics at the time of RRT initiation
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Distribution of criteria which mandated RRT initiation in the more-delayed strategy group* (111 patients of 141 in this group actually received RRT)
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Characteristics of RRT sessions delivered during the 28 days following randomization
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SERUM CREATININE VALUES AT DIFFERENT STAGE
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SERUM CREATININE VALUES AT DIFFERENT STAGE
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POST-HOC ANALYSIS ACCORDING TO RENAL INCLUSION CRITERIA
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discussion
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Discussion Duration of oliguria or anuria was no longer an indication for initiating RRT and the concentration of blood urea nitrogen that mandated initiation was set to a higher value (140 mg/dL instead of 112 in the AKIKI study) in the more-delayed strategy Survival did not differ between groups either at day 28 or day 60 Multivariable analysis revealed that 60-day mortality was higher with the more-delayed strategy
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Discussion Mortality rate did not significantly differ between early and delayed strategies, and significantly less severe adverse effects as well as better renal recovery were observed when RRT was delayed in patients who had no severe complication of acute kidney injury Last difficulty remains in defining the appropriate duration of the postponement of RRT Analysis of adjusted day-60 mortality revealed a significant increase in mortality with the more-delayed strategy The reasons for this finding are unclear as there were no differences between strategies in the rate of complications, or in the length of ICU and hospital stay
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Discussion Longer duration of delay of therapy initiation, the greater percentage of patients who did not receive RRT median delay STARRT-AKI study 25 hr IDEAL-ICU trial 48 hr AKIKI study 57 hr AKIKI2 study 94 hr Patients avoided RRT 38% - 49% Deleting oliguria or anuria duration as a criterion for initiating RRT and increasing the threshold of blood urea nitrogen allowed for testing the practicability and safety of an extension of the delay of initiation in the present study
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Discussion Concentration of blood urea nitrogen was allowed per protocol to rise greater than 112 mg/dL in the more-delayed strategy This strategy was associated with a worsened prognosis This study gives objective credence to the limit that the concentration of blood urea nitrogen should not exceed
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Critical appraisal
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P Patients > 18 years who admitted to ICU with AKI stage 3 and receiving invasive mechanical ventilation, catecholamine infusion or both I Delayed RRT strategy C More-delayed RRT strategy O Primary endpoint was RRT-free days between randomisation and day 28
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Computer-generated, balanced by blocks of variable and undisclosed size, and stratified per centre
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Thank you