A Protocol for the Nigerian Neonatal Acute Kidney Injury Continuum Prospective Study
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SUBMITTER: Alao M
PROVIDER: S-EPMC10658228 | biostudies-literature | 2023 Aug
REPOSITORIES: biostudies-literature
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Project description:Background: Acute kidney injury (AKI) is a significant problem in neonates, but the evidence is sparse. Neonatal AKI is an independent risk factor for increased mortality and prolonged hospital stay. There are stark differences in the epidemiology of AKI in neonates amongst the developing and the developed world. Increased prevalence of neonatal sepsis, lack of awareness about neonatal AKI and poor access to pediatric nephrologists add to the improper management of neonatal AKI in the developing countries. Methods: This study is a multicentric, national, prospective cohort study [The Indian iconic Neonatal Kidney Educational Registry (TINKER)] conducted in level 2-3 NICUs in 11 centers across India. We have enrolled nearly 2,000 neonates over the study period. Neonates (≤ 28 days) who were admitted in NICU and those who received intravenous (IV) fluids for at least 48 h for hydration and/or nutrition have been included. Data collection included: (1) baseline demographics (2) daily physiologic and laboratory parameters (3) discharge data. KDIGO workgroup AKI definition modified for neonates was used for defining AKI. Data entry was carried out by individual participating centers using a web-based database (akiregistry.org). De-identified data has been maintained and handled by the principal investigator (PI). This collaboration plans to disseminate data through peer-reviewed publications and through presentations at educational conferences. Conclusions: The purpose of this study is to create the first prospective neonatal all-cause AKI data repository and describe the incidence of neonatal AKI in NICUs in the country and determine the risk factors as well as the outcomes of such neonates-both short-term and long-term outcomes. This will eventually spur therapeutic advancements, facilitate decipherment of epidemiological trends, risk factors as well as outcomes and identify disparities in management across the nation.
| S-EPMC8300429 | biostudies-literature
Project description:BackgroundAcute kidney injury (AKI) is associated with high morbidity and mortality. The continuum of kidney damage after an AKI episode is poorly explored in the paediatric population.MethodsWe performed a retrospective cohort study on 2346 children with AKI from a tertiary care hospital in Romania over a 9-year period. The main objective was to evaluate the impact of AKI duration on mortality and the risk of new-onset chronic kidney disease (CKD).ResultsOut of 2346 AKI patients, transient AKI was present in 655 patients (27.9%), persistent AKI in 1009 children (43%) and acute kidney disease in 682 patients (29.1%). In contrast to transient AKI, children who developed acute kidney disease were younger, with a higher degree of anaemia, lower number of platelets, higher procalcitonin, higher LDH, higher GGT, higher urea and higher serum creatinine levels. The pre-renal cause of AKI was the leading cause regardless of AKI duration. As kidney injury progressed over time, there was an increasing incidence of the intrinsic causes of AKI (11.1% in transient AKI, 13.2% in persistent AKI and 22.6% in acute kidney disease). Acute kidney disease patients had the highest mortality rate (16.42%), followed by transient AKI (14.66%) and persistent AKI (9.81%). Overall mortality increased in the presence of renal microvascular alterations, acute tubular necrosis, lower haemoglobin, serum proteins and platelets, and higher procalcitonin levels.ConclusionsThe continuum of AKI expressed as acute kidney disease resulted in an increased risk of new-onset CKD. CKD was influenced by the intrinsic cause of AKI and not by AKI severity.
| S-EPMC11663817 | biostudies-literature
Project description:BackgroundMost studies of neonatal acute kidney injury (AKI) have focused on the first week following birth. Here, we determined the outcomes and risk factors for late AKI (>7d).MethodsThe international AWAKEN study examined AKI in neonates admitted to an intensive care unit. Late AKI was defined as occurring >7 days after birth according to the KDIGO criteria. Models were constructed to assess the association between late AKI and death or length of stay. Unadjusted and adjusted odds for late AKI were calculated for each perinatal factor.ResultsLate AKI occurred in 202/2152 (9%) of enrolled neonates. After adjustment, infants with late AKI had higher odds of death (aOR:2.1, p = 0.02) and longer length of stay (parameter estimate: 21.9, p < 0.001). Risk factors included intubation, oligo- and polyhydramnios, mild-moderate renal anomalies, admission diagnoses of congenital heart disease, necrotizing enterocolitis, surgical need, exposure to diuretics, vasopressors, and NSAIDs, discharge diagnoses of patent ductus arteriosus, necrotizing enterocolitis, sepsis, and urinary tract infection.ConclusionsLate AKI is common, independently associated with poor short-term outcomes and associated with unique risk factors. These should guide the development of protocols to screen for AKI and research to improve prevention strategies to mitigate the consequences of late AKI.
| S-EPMC6438709 | biostudies-literature
Project description:BackgroundAcute kidney injury (AKI) is frequent and associated with poor outcome in intensive care unit (ICU) patients. Besides the association with short- and long-term mortality, the increased risk of chronic kidney disease (CKD) has been recently highlighted in non-ICU patients. This study aims to describe the incidence and determinants of CKD after AKI and to develop a prediction score for CKD in ICU patients.MethodsProspective multicenter (n = 17) observational study included 1200 ICU patients who suffered from AKI (defined by an AKIN stage ≥ 1) during their ICU stay and were discharged alive from ICU. Preexisting end-stage renal disease (ESRD) and immunosuppressant treatments are the main exclusion criteria. Patients will be monitored by a nephrologist at day 90 and every year for 3 years. The main outcome is the occurrence of CKD defined by a creatinine-based estimated glomerular filtration rate (eGFR) lower than 60 mL/min/1.73 m2 or renal replacement therapy for ESRD in patients whose eGFR will be normalized (≥ 60 mL/min/1.73 m2) at day 90. Secondary outcomes include albuminuria changes, eGFR decline slope and ESRD risk in patients with preexisting CKD, cardiovascular and thromboembolic events and health-related quality of life.DiscussionThis is the first study prospectively investigating kidney function evolution in ICU patients who suffered from AKI. Albuminuria and eGFR monitoring will allow to identify ICU patients at risk of CKD who may benefit from close surveillance after recovering from AKI. Major patient and AKI-related determinants will be tested to develop a prediction score for CKD in this population. Trial registration ClinicalTrials.gov, NCT03282409. Registered on September 14, 2017.
| S-EPMC6035124 | biostudies-literature
Project description:BackgroundCurrent information about acute kidney injury (AKI) epidemiology in developing nations derives mainly from isolated centers, with few quality multicentric epidemiological studies. Our objective was to describe a large cohort of patients with dialysis-requiring AKI derived from ordinary clinical practice within a large metropolitan area of an emerging country, assessing the impact of age and several clinical predictors on patient survival across the spectrum of human life.MethodsWe analyzed registries drawn from 170 hospitals and medical facilities in Rio de Janeiro, Brazil, in an eleven-year period (2002-2012). The study cohort was comprised of 17,158 pediatric and adult patients. Data were analyzed through hierarchical logistic regression models and mixed-effects Cox regression for survival comparison across age strata.ResultsSevere AKI was mainly hospital-acquired (72.6%), occurred predominantly in the intensive care unit (ICU) (84.9%), and was associated with multiple organ failure (median SOFA score, 11; IQR, 6-13). The median age was 75 years (IQR, 59-83; range, 0-106 years). Community-acquired pneumonia was the most frequent admission diagnosis (23.8%), and sepsis was the overwhelming precipitating cause (72.1%). Mortality was 71.6% and was higher at the age extremes. Poor outcomes were driven by age, mechanical ventilation, vasopressor support, liver dysfunction, type 1 cardiorenal syndrome, the number of failing organs, sepsis at admission, later sepsis, the Charlson score, and ICU admission. Community-acquired AKI, male gender, and pre-existing chronic kidney disease were associated with better outcomes.ConclusionsOur study adds robust information about the real-world epidemiology of dialysis-requiring AKI with considerable clinical detail. AKI is a heterogeneous syndrome with variable clinical presentations and outcomes, including differences in the age of presentation, comorbidities, frailty state, precipitation causes, and associated diseases. In the cohort studied, AKI characteristics bore more similarities to upper-income countries as opposed to the pattern traditionally associated with resource-limited economies.
| S-EPMC9071163 | biostudies-literature
Project description:BackgroundWe aimed to describe nephrotoxic medication exposure and investigate associations between exposure and acute kidney injury (AKI) in the neonatal intensive care unit during the first postnatal week.Design/methodsSecondary analysis of the AWAKEN cohort. We evaluated nephrotoxic medication exposure during the first postnatal week and associations with AKI using time-varying Cox proportional hazard regressions models. Nephrotoxic medication exposure categories were defined as: no nephrotoxic medication, nephrotoxic medications excluding aminoglycosides, aminoglycoside alone, and aminoglycoside and another nephrotoxic medication.ResultsOf 2162 neonates, 1616 (74.7%) received ≥1 nephrotoxic medication. Aminoglycoside receipt was most common (72%). AKI developed in 211(9.8%) neonates and was associated with a nephrotoxic medication exposure (p < 0.01). Nephrotoxic medication exposures including a nephrotoxic medication excluding aminoglycoside (aHR 3.14, 95% CI 1.31-7.55) and aminoglycoside and another nephrotoxic medication (aHR 4.79, 95% CI 2.19-10.50) were independently associated with AKI and severe AKI (stage 2/3), respectively.ConclusionsNephrotoxic medication exposure in critically ill infants is common during the first postnatal week. Specific nephrotoxic medication exposure, principally aminoglycosides with another nephrotoxic medication, are independently associated with early AKI.
| S-EPMC10725773 | biostudies-literature
Project description:BackgroundThe relationship between cardiac output and septic acute kidney injury (AKI) remains unclear. The purpose of this study was to assess the association between the cardiac index (CI) and the renal outcomes in patients with septic shock.MethodsA one-year prospective cohort study was performed in the surgical and medical ICU of a teaching hospital in Nanjing, China. Twenty-nine septic shock patients who required early goal-directed fluid resuscitation were consecutively included. Pulse indicator continuous cardiac output (PiCCO) device was used to measure hemodynamic parameters before and after early goal-directed therapy (EGDT). Based on CI changes after EGDT, patients were assign to the CI increased group or the CI constant group, respectively. The incidence of poor renal outcome, which was defined as AKI on admission without recovery in following three days or new onset AKI within 28 days, was recorded. We investigated whether an increased CI was associated with a better renal outcome.ResultsAfter EGDT, there were 16 patients in the CI increased group and 13 patients in the CI constant group. The incidence of poor renal outcome was lower in CI increased group than in the CI constant group (6% vs. 62%; P = 0.003) with a relative risk of 0.10. The logistic regression showed that the CI percent change was associated with renal outcome, with an odd ratio of 0.003 (P = 0.056) after adjustment of possible confounding factors. The CI percent change would predict a good renal outcome (AU ROC 0.739, P = 0.012) with moderate accuracy (sensitivity 75% and specificity 89%) when using a 10% cut-off value from Youden index. The CI percent change was also positively correlated with creatinine clearance (CCr) after EGDT (ρ = 0.548; P = 0.002).ConclusionsThe increased CI after EGDT was a protective factor for kidney in patients with septic shock. A CI increased above 10% could be potentially used to predict development and reversibility of AKI in septic shock patients.Trial registrationClinicaltrials.gov:NCT01862588 (May 13, 2013).
| S-EPMC4350650 | biostudies-literature
Project description:Acute kidney injury (AKI) has been reported to be associated with excess risks of death, kidney disease progression and cardiovascular events although previous studies have important limitations. To further examine this, we prospectively studied adults from four clinical centers surviving three months and more after hospitalization with or without AKI who were matched on center, pre-admission CKD status, and an integrated priority score based on age, prior cardiovascular disease or diabetes mellitus, preadmission estimated glomerular filtration rate (eGFR) and treatment in the intensive care unit during the index hospitalization between December 2009-February 2015, with follow-up through November 2018. All participants had assessments of kidney function before (eGFR) and at three months and annually (eGFR and proteinuria) after the index hospitalization. Associations of AKI with outcomes were examined after accounting for pre-admission and three-month post-discharge factors. Among 769 AKI (73% Stage 1, 14% Stage 2, 13% Stage 3) and 769 matched non-AKI adults, AKI was associated with higher adjusted rates of incident CKD (adjusted hazard ratio 3.98, 95% confidence interval 2.51-6.31), CKD progression (2.37,1.28-4.39), heart failure events (1.68, 1.22-2.31) and all-cause death (1.78, 1.24-2.56). AKI was not associated with major atherosclerotic cardiovascular events in multivariable analysis (0.95, 0.70-1.28). After accounting for degree of kidney function recovery and proteinuria at three months after discharge, the associations of AKI with heart failure (1.13, 0.80-1.61) and death (1.29, 0.84-1.98) were attenuated and no longer significant. Thus, assessing kidney function recovery and proteinuria status three months after AKI provides important prognostic information for long-term clinical outcomes.
| S-EPMC7374148 | biostudies-literature
Project description:ObjectivesTo describe study design considerations and to simulate a trial of biomarker-guided sepsis management aimed to reduce acute kidney injury (acute kidney injury). Tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7, urinary biomarkers of cell-cycle arrest, and indicators of kidney stress can detect acute kidney injury before clinical manifestations. We sought to determine the event rates for acute kidney injury as a function of serial measurements of urinary (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) in patients at risk of sepsis-associated acute kidney injury, so that an escalating series of kidney-sparing sepsis bundles based on international guidelines could be applied.DesignWe described the study protocol of "Limiting acute kidney injury Progression In Sepsis," a phase 4, multicenter, adaptive, randomized controlled trial. We performed simulations to estimate the rates for the trial's primary endpoint using patient-level data from two previous studies (Sapphire and Protocolized Care for Early Septic Shock).SettingAcademic and community ICUs.PatientsCritically ill patients with sepsis or septic shock, without evidence of stage 2/3 acute kidney injury at enrollment.InterventionsNone.Measurements and main resultsOur primary endpoint is progression of two or more stages of acute kidney injury, death, or dialysis within 72 hours after enrollment. In the Sapphire simulation, 45 of 203 patients (22%) with sepsis met the endpoint. In Protocolized Care for Early Septic Shock, 144 of 607 patients (24%) with septic shock met the endpoint. In both simulations, (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) patterns, suggested by Limiting acute kidney injury Progression In Sepsis protocol, stratified the risk for the endpoint from 6% (three negative tests) to 41% (for patients eligible for the highest level of kidney-sparing sepsis bundle) in Sapphire, and 14% (two negative tests) to 46% (for the highest level of kidney-sparing sepsis bundle) in Protocolized Care for Early Septic Shock.ConclusionsFindings of our Limiting acute kidney injury Progression In Sepsis trial simulation confirmed that (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) could identify patients with different rates of progression to moderate/severe acute kidney injury, death, or dialysis in 72 hours. The Limiting acute kidney injury Progression In Sepsis protocol algorithm is therefore feasible in terms of identifying suitably high-risk individuals for kidney-sparing sepsis bundle.
| S-EPMC8439672 | biostudies-literature
Project description:IntroductionAcute kidney injury (AKI) affects more than 50% of critically ill patients. The formation of calcitriol, the active vitamin D metabolite, from the main inactive circulating form, 25-hydroxyvitamin D (25(OH)D), occurs primarily in the proximal renal tubules. This results in a theoretical basis for reduction in levels of calcitriol over the course of an AKI. Vitamin D deficiency is highly prevalent in critically ill adults, and has been associated with increased rates of sepsis, longer hospital stays and increased mortality. The primary objective of this study is to perform serial measurements of 25(OH)D and calcitriol (1,25(OH)2D), as well as parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) levels, in critically ill adult patients with and without AKI, and to determine whether patients with AKI have significantly lower vitamin D metabolite concentrations. The secondary objectives are to describe dynamic changes in vitamin D metabolites, PTH and FGF23 during critical illness; to compare vitamin D metabolite concentrations in patients with AKI with and without renal replacement therapy; and to investigate whether there is an association between vitamin D status and outcomes.Methods and analysis230 general adult intensive care patients will be recruited. The AKI arm will include 115 critically ill patients with AKI Kidney Disease Improving Global Outcome stage II or stage III. The comparison group will include 115 patients who require cardiovascular or respiratory support, but who do not have AKI. Serial measurements of vitamin D metabolites and associated hormones will be taken on prespecified days. Patients will be recruited from two large teaching Trusts in England. Data will be analysed using standard statistical methods.Ethics and disseminationEthical approval was obtained. Upon completion, the study team will submit the study report for publication in a peer-reviewed scientific journal and for conference presentation.Trial registration numberNCT02869919; Pre-results.
| S-EPMC5726075 | biostudies-literature