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Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in critically ill children (AWARE): study protocol for a prospective observational study.

ABSTRACT: Acute kidney injury (AKI) is associated with poor outcome in critically ill children. While data extracted from retrospective study of pediatric populations demonstrate a high incidence of AKI, the literature lacks focused and comprehensive multicenter studies describing AKI risk factors, epidemiology, and outcome. Additionally, very few pediatric studies have examined novel urinary biomarkers outside of the cardiopulmonary bypass population.This is a prospective observational study. We anticipate collecting data on over 5000 critically ill children admitted to 31 pediatric intensive care units (PICUs) across the world during the calendar year of 2014. Data will be collected for seven days on all children older than 90 days and younger than 25 years without baseline stage 5 chronic kidney disease, chronic renal replacement therapy, and outside of 90 days of a kidney transplant or from surgical correction of congenital heart disease. Data to be collected includes demographic information, admission diagnoses and co-morbidities, and details on fluid and vasoactive resuscitation used. The renal angina index will be calculated integrating risk factors and early changes in serum creatinine and fluid overload. On days 2-7, all hemodynamic and pertinent laboratory values will be captured focusing on AKI pertinent values. Daily calculated values will include % fluid overload, fluid corrected creatinine, and KDIGO AKI stage. Urine will be captured twice daily for biomarker analysis on Days 0-3 of admission. Biomarkers to be measured include neutrophil gelatinase lipocalin (NGAL), kidney injury molecule-1 (KIM-1), liver-type fatty acid binding protein (l-FABP), and interleukin-18 (IL-18). The primary outcome to be quantified is incidence rate of severe AKI on Day 3 (Day 3-AKI). Prediction of Day 3-AKI by the RAI and after incorporation of biomarkers with RAI will be analyzed.The Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology (AWARE) study, creates the first prospective international pediatric all cause AKI data warehouse and biologic sample repository, providing a broad and invaluable resource for critical care nephrologists seeking to study risk factors, prediction, identification, and treatment options for a disease syndrome with high associated morbidity affecting a significant proportion of hospitalized children.ClinicalTrials.gov: NCT01987921.

SUBMITTER: Basu RK

PROVIDER: S-EPMC4355130 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in critically ill children (AWARE): study protocol for a prospective observational study.

Basu Rajit K RK Kaddourah Ahmad A Terrell Tara T Mottes Theresa T Arnold Patricia P Jacobs Judd J Andringa Jennifer J Goldstein Stuart L SL

BMC nephrology 20150226

<h4>Background</h4>Acute kidney injury (AKI) is associated with poor outcome in critically ill children. While data extracted from retrospective study of pediatric populations demonstrate a high incidence of AKI, the literature lacks focused and comprehensive multicenter studies describing AKI risk factors, epidemiology, and outcome. Additionally, very few pediatric studies have examined novel urinary biomarkers outside of the cardiopulmonary bypass population.<h4>Methods/design</h4>This is a pr ...[more]

PMID: 25882434

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Project description:Acute kidney injury (AKI) is associated with poor outcomes in critically ill children. Recent international consensus panels recommend standardized classification systems to improve the precision of AKI diagnosis, but there is a paucity of data to enable this refinement, particularly in pediatric critical care. This is a prospective observational study. We anticipate collecting data from more than 5500 critically ill children admitted to 32 pediatric intensive care units (PICUs) across the world, during the calendar year of 2014. Data will be collected continuously for three months at each center on all children older than 90 days and younger than 25 years admitted to the ICU. Demographic, resuscitative, and daily physiological and lab data will be captured at individual centers using MediData Rave™, a commercial system designed to manage and report clinical research data. Kidney specific measured variables include changes in serum creatinine and urine output, cumulative fluid overload (%), serum creatinine corrected for fluid balance, and KDIGO AKI stage. Urinary AKI biomarkers to be measured include: urinary neutrophil gelatinase lipocalin (NGAL), kidney injury molecule-1 (KIM-1), liver-type fatty acid binding protein (l-FABP), and interleukin-18 (IL-18). Biomarker combinations will be created from different pairs and triplets of urinary biomarkers. The primary analysis will compare the discrimination of these panels versus changes in creatinine for prediction of severe AKI by Day 7 of ICU admission. Secondary analysis will investigate the prediction of biomarkers for injury 'time based phenotypes': duration (>2 days), severity (KDIGO stage, use of renal replacement therapy), reversibility (time to return of serum creatinine to baseline), association with fluid overload > 10%, and disease association (sepsis, hypovolemia, hypoxemia, or nephrotoxic). The Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology (AWARE) study will be the largest ever prospective study of any disease process in pediatric critical care. Data from AWARE will enable refinement of AKI classification. AWARE creates the largest ever all-cause pediatric AKI data warehouse and biologic sample repository, providing a broad and invaluable resource for critical care nephrologists seeking to study risk factors, prediction, identification, and treatment options for a disease syndrome with high associated morbidity affecting a significant proportion of hospitalized children. Improving the precision of AKI diagnosis using biomarker combinations provides a foundation for targeted, personalized therapy for different injury phenotypes. NCT01987921.

Project description:BackgroundAcute kidney injury (AKI) occurs in one in four children admitted to the intensive care unit (ICU) and AKI severity is independently associated with increased patient morbidity and mortality. Early prediction of AKI has the potential to improve outcomes. In smaller, single center populations, we have previously derived and validated the performance of the renal angina index (RAI), a context driven risk stratification system, to predict severe AKI.MethodsA prospective, observational study (AWARE1, January-December 2014) was conducted in intensive care units from 32 centers in 9 countries. The primary outcome was the presence of severe AKI ("AKIS"; Stage 2-3 AKI KDIGO guidelines) on the third day after ICU admission (). We compared the performance of the RAI to changes in serum creatinine relative to baseline (SCr/Base) for prediction of the primary outcome and secondary outcomes of interest. A RAI ≥ 8 defined fulfillment of renal angina (RA+); RA+ was compared to SCr increased relative to baseline ("SCr>Base"; using maximum SCr in first 12 hours of ICU admission).FindingsThe 1590 patients studied were 55% male and had median age of 54.5 months. 286 patients (17.9%) were RA+. AKIS occurred in 121 (42.3%) RA+ vs. 247 (18.9%) RA-patients (relative risk (RR) 2.23; 95% confidence interval (CI): 1.87-2.66, p<0.001). 368 (23.1%) patients with AKIS had increased renal replacement therapy utilization (10.9% vs. 1.5%, p<0.001) and increased mortality (7.6% vs. 4.3%, p=0.01) compared to patients without AKIS. RA+ demonstrated better prediction for AKIS than SCr>Base (RR: 1.61; (1.33-1.93), p<0.001) which was maintained on multivariate regression (independent odds ratio (OR): RA+ 3.21; 95% CI (2.20-4.67) vs. SCr>Base 0.68; 95% CI (0.49-4.94)).InterpretationEarlier, better prediction of severe AKI has the potential to improve AKI associated patient outcomes. Compared to isolated, context-free changes in SCr, renal angina risk assessment improved accuracy for prediction of severe AKI in critically ill children and young adults.

Project description:BackgroundThe renal angina index (RAI) is a tool that has been validated by several studies in the pediatric population to predict the development of severe acute kidney injury (AKI). The aims of this study were to evaluate the efficacy of the RAI in predicting severe AKI in critically ill patients with COVID-19 and to propose a modified RAI (mRAI) for this population.MethodsThis was a prospective cohort analysis of all COVID-19 patients receiving invasive mechanical ventilation (IMV) who were admitted to the intensive care unit (ICU) of a third-level hospital in Mexico City from 03/2020 to 01/2021. AKI was defined according to KDIGO guidelines. The RAI score was calculated for all enrolled patients using the method of Matsuura. Since all patients had the highest score for the condition (due to receiving IMV), the score corresponded to the delta creatinine (ΔSCr) value. The main outcome was severe AKI (stage 2 or 3) at 24 and 72 h after ICU admission. A logistic regression analysis was applied to search for factors associated with the development of severe AKI, and the data were applied to develop a mRAI and compare it vis-à-vis the efficacy of both scores (RAI and mRAI).ResultsOf the 452 patients studied, 30% developed severe AKI. The original RAI score was associated with AUCs of 0.67 and 0.73 at 24 h and 72 h, respectively, with a cutoff of 10 points to predict severe AKI. In the multivariate analysis adjusted for age and sex, a BMI ≥30 kg/m2, a SOFA score ≥6, and Charlson score were identified as risk factors for the development of severe AKI. In the new proposed score (mRAI), the conditions were summed and multiplied by the ΔSCr value. With these modifications, the AUC improved to 0.72 and 0.75 at 24 h and 72 h, respectively, with a cutoff of 8 points.ConclusionsThe original RAI is a limited tool for patients with critical COVID-19 receiving IMV. The mRAI, with the parameters proposed in the present study, improves predictive performance and risk stratification in critically ill patients receiving IMV.

Project description:BackgroundAcute kidney injury (AKI) complicates shock. Diagnosis is based on rising creatinine, a late phenomenon. Intrarenal vasoconstriction occurs earlier. Measuring flow resistance in the renal circulation, Renal Resistive Index (RRI), could become part of vital organ function assessment using Doppler ultrasound. Our aim was to determine whether RRI on ICU admission is an early predictor and discriminator of AKI developed within the first week.MethodsIn this prospective cohort of mixed ICU patients with and without shock, RRI was measured <24-h of admission. Besides routine variables, sublingual microcirculation and bioelectrical impedance were measured. AKI was defined by the Kidney Disease Improving Global Outcomes criteria. Uni- and multivariate regression and Receiver Operating Characteristics curve analyses were performed.ResultsNinety-nine patients were included, median age 67 years (IQR 59-75), APACHE III score 67 (IQR 53-89). Forty-nine patients (49%) developed AKI within the first week. AKI patients had a higher RRI on admission than those without: 0.71 (0.69-0.73) vs. 0.65 (0.63-0.68), p = 0.001. The difference was significant for AKI stage 2: RRI = 0.72 (0.65-0.80) and 3: RRI = 0.74 (0.67-0.81), but not for AKI stage 1: RRI = 0.67 (0.61-0.74). On univariate analysis, RRI significantly predicted AKI 2-3: OR 1.012 (1.006-1.019); Area Under the Curve (AUC) of RRI for AKI 2-3 was 0.72 (0.61-0.83), optimal cut-off 0.74, sensitivity 53% and specificity 87%. On multivariate analysis, RRI remained significant, independent of APACHE III and fluid balance; adjusted OR: 1.008 (1.000-1.016).ConclusionsHigh RRI on ICU admission was a significant predictor for development of AKI stage 2-3 during the first week. High RRI can be used as an early warning signal RRI, because of its high specificity. A combined score including RRI, APACHE III and fluid balance improved AKI prediction, suggesting that vasoconstriction or poor vascular compliance, severity of disease and positive fluid balance independently contribute to AKI development.Trial registrationClinicalTrials.gov NCT02558166.

Project description:BackgroundThe epidemiologic characteristics of children and young adults with acute kidney injury have been described in single-center and retrospective studies. We conducted a multinational, prospective study involving patients admitted to pediatric intensive care units to define the incremental risk of death and complications associated with severe acute kidney injury.MethodsWe used the Kidney Disease: Improving Global Outcomes criteria to define acute kidney injury. Severe acute kidney injury was defined as stage 2 or 3 acute kidney injury (plasma creatinine level ≥2 times the baseline level or urine output <0.5 ml per kilogram of body weight per hour for ≥12 hours) and was assessed for the first 7 days of intensive care. All patients 3 months to 25 years of age who were admitted to 1 of 32 participating units were screened during 3 consecutive months. The primary outcome was 28-day mortality.ResultsA total of 4683 patients were evaluated; acute kidney injury developed in 1261 patients (26.9%; 95% confidence interval [CI], 25.6 to 28.2), and severe acute kidney injury developed in 543 patients (11.6%; 95% CI, 10.7 to 12.5). Severe acute kidney injury conferred an increased risk of death by day 28 after adjustment for 16 covariates (adjusted odds ratio, 1.77; 95% CI, 1.17 to 2.68); death occurred in 60 of the 543 patients (11.0%) with severe acute kidney injury versus 105 of the 4140 patients (2.5%) without severe acute kidney injury (P<0.001). Severe acute kidney injury was associated with increased use of mechanical ventilation and renal-replacement therapy. A stepwise increase in 28-day mortality was associated with worsening severity of acute kidney injury (P<0.001 by log-rank test). Assessment of acute kidney injury according to the plasma creatinine level alone failed to identify acute kidney injury in 67.2% of the patients with low urine output.ConclusionsAcute kidney injury is common and is associated with poor outcomes, including increased mortality, among critically ill children and young adults. (Funded by the Pediatric Nephrology Center of Excellence at Cincinnati Children's Hospital Medical Center and others; AWARE ClinicalTrials.gov number, NCT01987921 .).

Dataset Information

Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in critically ill children (AWARE): study protocol for a prospective observational study.

Publications

Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in critically ill children (AWARE): study protocol for a prospective observational study.

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