Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury
Ting LiBuyun WuLi LiAo BianJuan NiKang LiuZhongke QinYudie PengYining ShenMengru LvXinyi LuChangying XingHuijuan Mao
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Importance Despite the expansion of published electronic alerts for acute kidney injury (AKI), there are still concerns regarding their effect on the clinical outcomes of patients. Objective To evaluate the effect of the AKI alert combined with a care bundle on the care and clinical outcomes of patients with hospital-acquired AKI. Design, Setting, and Participants This single-center, double-blind, parallel-group randomized clinical trial was conducted in a tertiary teaching hospital in Nanjing, China, from August 1, 2019, to December 31, 2021. The inclusion criteria were inpatient adults aged 18 years or older with AKI, which was defined using the Kidney Disease: Improving Global Outcomes creatinine criteria. Participants were randomized 1:1 to either the alert group or the usual care group, which were stratified by medical vs surgical ward and by intensive care unit (ICU) vs non-ICU setting. Analyses were conducted on the modified intention-to-treat population. Interventions A programmatic AKI alert system generated randomization automatically and sent messages to the mobile telephones of clinicians (alert group) or did not send messages (usual care group). A care bundle accompanied the AKI alert and consisted of general, nonindividualized, and nonmandatory AKI management measures. Main Outcomes and Measures The primary outcome was maximum change in estimated glomerular filtration rate (eGFR) within 7 days after randomization. Secondary patient-centered outcomes included death, dialysis, AKI progression, and AKI recovery. Care-centered outcomes included diagnostic and therapeutic interventions for AKI. Results A total of 2208 patients (median [IQR] age, 65 [54-72] years; 1560 males [70.7%]) were randomized to the alert group (n = 1123) or the usual care group (n = 1085) and analyzed. Within 7 days of randomization, median (IQR) maximum absolute changes in eGFR were 3.7 (−6.4 to 19.3) mL/min/1.73 m 2 in the alert group and 2.9 (−9.2 to 16.9) mL/min/1.73 m 2 in the usual care group ( P = .24). This result was robust in all subgroups in an exploratory analysis. For care-centered outcomes, patients in the alert group had more intravenous fluids (927 [82.6%] vs 670 [61.8%]; P &lt; .001), less exposure to nonsteroidal anti-inflammatory drugs (56 [5.0%] vs 119 [11.0%]; P &lt; .001), and more AKI documentation at discharge (560 [49.9%] vs 296 [27.3%]; P &lt; .001) than patients in the usual care group. No differences were observed in patient-centered secondary outcomes between the 2 groups. Conclusions and Relevance Results of this randomized clinical trial showed that the electronic AKI alert did not improve kidney function or other patient-centered outcomes but changed patient care behaviors. The findings warrant the use of a combination of high-quality interventions and AKI alert in future clinical practice. Trial Registration ClinicalTrials.gov Identifier: NCT03736304Background Acute kidney injury is common in critically ill patients with detrimental effects on mortality, length of stay and post-discharge outcomes. The Acute Kidney Injury Network developed guidelines based on urine output and serum creatinine to classify patients into stages of acute kidney injury. Methods In this analysis we utilize the Acute Kidney Injury Network guidelines to evaluate the acute kidney injury stage in patients admitted to general and cardiac intensive care units over a period of 18 months. Acute kidney injury stage was calculated in real time hourly based on the guidelines and using these temporal stage scores calculated for the population; the prevalence and progression of acute kidney injury stage was compared between the two units. We hypothesized that the prevalence and progression of acute kidney injury stage between the two units may be different. Results More cardiac intensive care unit patients had no acute kidney injury (stage <1) during their intensive care unit stay but more cardiac intensive care unit patients developed acute kidney injury (stage >1), compared to the General Intensive Care Unit. Both at intensive care unit admission and discharge, more General Intensive Care Unit patients had acute kidney injury; however, the number of cardiac intensive care unit patients with acute kidney injury was three times higher at discharge than admission. Acute kidney injury developed in a different pattern in the two intensive care units over five days of intensive care unit stay. In the General Intensive Care Unit, acute kidney injury was most prevalent on second day of intensive care unit stay and in cardiac intensive care unit acute kidney injury was most prevalent on the third day of intensive care unit stay. We observed the biggest increase in new acute kidney injury in the first day of General Intensive Care Unit and second day of the cardiac intensive care unit stay. Conclusions The study demonstrates the different trends of acute kidney injury pattern in general and cardiac intensive care unit patient populations highlighting the earlier development of acute kidney injury on General Intensive Care Unit and more prevalence of acute kidney injury on discharge from cardiac intensive care unit.
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Aims: The development of acute kidney injury (AKI) in the postoperative period is associated with increased morbidity and mortality. This study aims to determine the incidence of postoperative acute kidney injury (AKI) and the factors affecting the development of AKI in the intensive care unit (ICU) and to evaluate the outcomes of the patients.
Methods: Postoperative patients hospitalized in the ICU between December 2021 and January 2023 were retrospectively analyzed, and 192 patients were included in the study. Kidney disease: patients with and without AKI were identified using the improving global outcomes (KDIGO) criteria.
Results: While 150 of the patients did not develop AKI (non-AKI group), 42 of them developed acute kidney injury (AKI group). The patients were operated on mostly by the orthopedics clinic (58.9%) and operated on at least by the urology clinic (2.1%) were taken to the intensive care unit. 39.6% of the patients underwent emergency surgery, and 60.4% underwent elective surgery. 57.1% of the AKI group and 34.7% of the non-AKI group had emergency surgery (p=0.008).
Conclusion: In our study, age, timing of surgery, use of diuretics, and use of vasopressors were found to be associated with the development of postoperative AKI. In addition, comorbid diseases such as diabetes mellitus, hypertension, coronary artery disease, and cerebrovascular disease have also been found to be associated with AKI. Mortality, length of stay in the intensive care unit, and need for mechanical ventilation (MV) were also higher in our postoperative intensive care patients who developed AKI than in patients who did not develop AKI.
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Abstract Most randomized controlled trials use balanced randomization to achieve approximately or exactly equal sample sizes per group. However, in some settings imbalanced (unequal) randomization designs may be more powerful, less costly, and/or more ethically appealing to study participants. This article examines some important statistical rationales for unequal randomization designs. It covers both two‐arm and multi‐arm trial designs with either fixed or response‐adaptive randomization.
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Acute kidney injury occurs frequently in children during critical illness and is associated with increased morbidity, mortality, and health resource utilization. We aimed to examine the association between acute kidney injury duration and these outcomes.Retrospective cohort study.PICUs in Alberta, Canada.All children admitted to PICUs in Alberta, Canada between January 1, 2015, and December 31, 2015.None.In total, 1,017 children were included, and 308 (30.3%) developed acute kidney injury during PICU stay. Acute kidney injury was categorized based on duration to transient (48 hr or less) or persistent (more than 48 hr). Transient acute kidney injury occurred in 240 children (77.9%), whereas 68 children (22.1%) had persistent acute kidney injury. Persistent acute kidney injury had a higher proportion of stage 2 and stage 3 acute kidney injury compared with transient acute kidney injury and was more likely to start within 24 hours from PICU admission. Persistent acute kidney injury occurred more frequently in those with higher illness severity and in those admitted with shock, sepsis, or with a history of transplant. Mortality varied significantly according to acute kidney injury status: 1.8% of children with no acute kidney injury, 5.4% with transient acute kidney injury, and 17.6% with persistent acute kidney injury died during hospital stay (p < 0.001). On multivariable analysis adjusting for illness and acute kidney injury severity, transient and persistent acute kidney injury were both associated with fewer ventilation-free days at 28 days (-1.28 d; 95% CI, -2.29 to -0.26 and -4.85 d; 95% CI, -6.82 to -2.88), vasoactive support-free days (-1.07 d; 95% CI, -2.00 to -0.15 and -4.24 d; 95% CI, -6.03 to -2.45), and hospital-free days (-1.93 d; 95% CI, -3.36 to -0.49 and -5.25 d; 95% CI, -8.03 to -2.47), respectively.In critically ill children, persistent and transient acute kidney injury have different clinical characteristics and association with outcomes. Acute kidney injury, even when its duration is short, carries significant association with worse outcomes. This risk increases further if acute kidney injury persists longer independent of the degree of its severity.
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To determine whether the progression and/or improvement of acute kidney injury in critically ill children is associated with mortality.Retrospective.Multidisciplinary, tertiary care, 24-bed PICU.A TOTAL OF: 8,260 patients who were 1 month to 21 years old with no chronic kidney disease admitted between May 2003 and March 2012.We analyzed patients based on their acute kidney injury stage as per the Kidney Disease Improving Global Outcomes acute kidney injury serum creatinine staging criteria on ICU admission, peak (highest acute kidney injury stage reached), and trough (lowest acute kidney injury stage after the peak) during their ICU stay. Nonrenal organ dysfunction was measured with a modified Pediatric Logistic Organ Dysfunction score. The primary outcome was 28-day mortality. p values were based on Yates-corrected chi-square test and logistic regression.Of the 8,260 patients, 529 (6.4%) had acute kidney injury on ICU admission and 974 (11.8%) had acute kidney injury during their ICU course. The 28-day mortality was 2.7% for patients with no acute kidney injury and 25.3% for patients with acute kidney injury. Patients in whom acute kidney injury developed or had worsening acute kidney injury from admission to peak and reached acute kidney injury stage 2 or 3 had higher mortality than those who remained at an acute kidney injury stage 1 (17.3-17.8% vs 32.2-37.9%; p ≤ 0.003). Patients whose acute kidney injury resolved after the peak had lower mortality than those who retained the same degree of acute kidney injury (9-13.5% vs 37.3-44%; p ≤ 0.04). Patients with acute kidney injury that resolved still had higher mortality than those who never developed acute kidney injury (11.2% vs 2.7%; p < 0.001). Multivariate regression demonstrated that the association between mortality and acute kidney injury progression was independent of severity of illness at admission and the severity of nonrenal organ dysfunction during the first week of ICU stay (p ≤ 0.01).Progression of acute kidney injury per the Kidney Disease Improving Global Outcomes staging criteria is independently associated with increased mortality in the PICU while its improvement is associated with a stepwise decrease in mortality.
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Background and Purpose —We examined the frequency, course, and treatment of hypertension in the NINDS rt-PA Stroke Trial. Methods —Blood pressure (BP) was measured at the time of admission, at randomization, and then 36 times during the first 24 hours after randomization. Patients with a systolic BP of >185 mm Hg and a diastolic BP of >110 mm Hg at admission were defined as hypertensive before randomization, and those with a systolic BP of >180 mm Hg or a diastolic BP of >105 mm Hg within the first 24 hours after randomization were defined as hypertensive after randomization. Standardized clinical assessments were conducted at 24 hours and at 3 months. Post hoc analyses were conducted to evaluate the association of antihypertensive therapy with clinical outcomes. Results —Of the 624 patients, 121(19%) had hypertension on admission and 372 (60%) had hypertension in the 24 hours after randomization. The use of antihypertensive therapy before randomization (tPA 9%, placebo 9%) and after randomization (tPA 24%, placebo 29%) was similar between placebo- and tPA-treated patients. No adverse effects of prerandomization antihypertensive therapy on 3-month favorable outcome were detected for either the placebo- or tPA-treated groups. For placebo patients with hypertension in the 24 hours after randomization, clinical outcome measures were similar for those patients who did and did not receive antihypertensive therapy after randomization ( P ≥0.26); antihypertensive therapy was not associated with declines in BP ( P =0.44) or with abrupt declines ( P =0.14). Those tPA patients who were hypertensive after randomization and received antihypertensive therapy were less likely to have a favorable outcome at 3 months ( P <0.01) than those who were hypertensive and did not receive antihypertensive therapy. Conclusions —The frequency of hypertension and the use of antihypertensive therapy were similar between the tPA and placebo groups in the NINDS rt-PA Stroke Trial. In the placebo group, antihypertensive therapy was not associated with less favorable outcomes at 3 months; postrandomization antihypertensive therapy was associated with less favorable outcomes for the tPA patients who were hypertensive. However, because of the nonrandomized use of antihypertensive therapy and the many post hoc comparisons leading to type 1 errors, the significance of this observation is unclear. Careful attention to BP and gentle management remain warranted for stroke patients treated with tPA.
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AIM: To introduce the response-adaptive randomization,which is one of the randomization strategies in clinical trials.METHODS: The ideas and theories of the play-the-winner rule and randomized-play-the-winner rule,which are two procedures of response-adaptive randomization,are introduced.A simulation study is employed to compare response-adaptive randomization with traditional equal-probability allocation.The advantages and disadvantages of the randomization rules and the issues concerned in implementation of response-adaptive randomization are discussed.RESULTS: The results show that the response-adaptive randomization reduce the number of failures with little decrease in test power than in the case of traditional equal-probability allocation.CONCLUSION: The play-the-winner rule and randomized-play-the-winner rule deserve the attention of clinicians and statisticians and are suggested in clinical trials after a certain degree of improvement since it is better balanced of the issues between ethics and statistics.
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: To examine the effect of severity of acute kidney injury or renal recovery on risk-adjusted mortality across different intensive care unit settings. Acute kidney injury in intensive care unit patients is associated with significant mortality.: Retrospective observational study.: There were 325,395 of 617,927 consecutive admissions to all 191 Veterans Affairs ICUs across the country.: Large national cohort of patients admitted to Veterans Affairs ICUs and who developed acute kidney injury during their intensive care unit stay.: Outcome measures were hospital mortality, and length of stay. Acute kidney injury was defined as a 0.3-mg/dL increase in creatinine relative to intensive care unit admission and categorized into Stage I (0.3 mg/dL to <2 times increase), Stage II (> or =2 and <3 times increase), and Stage III (> or =3 times increase or dialysis requirement). Association of mortality and length of stay with acute kidney injury stages and renal recovery was examined. Overall, 22% (n = 71,486) of patients developed acute kidney injury (Stage I: 17.5%; Stage II: 2.4%; Stage III: 2%); 16.3% patients met acute kidney injury criteria within 48 hrs, with an additional 5.7% after 48 hrs of intensive care unit admission. Acute kidney injury frequency varied between 9% and 30% across intensive care unit admission diagnoses. After adjusting for severity of illness in a model that included urea and creatinine on admission, odds of death increased with increasing severity of acute kidney injury. Stage I odds ratio = 2.2 (95% confidence interval, 2.17-2.30); Stage II odds ratio = 6.1 (95% confidence interval, 5.74, 6.44); and Stage III odds ratio = 8.6 (95% confidence interval, 8.07-9.15). Acute kidney injury patients with sustained elevation of creatinine experienced higher mortality risk than those who recovered.: None.: Admission diagnosis and severity of illness influence frequency and severity of acute kidney injury. Small elevations in creatinine in the intensive care unit are associated with increased risk-adjusted mortality across all intensive care unit settings, whereas renal recovery was associated with a protective effect. Strategies to prevent even mild acute kidney injury or promote renal recovery may improve survival.
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Abstract Simple randomization consists of allocating treatments to patients with equal probability. Attempts to improve over simple randomization stem from the desire (i) to ensure that a prespecified number of patients is enrolled in each treatment arm, (ii) to ensure balance with respect to important baseline prognostic factors across all treatment arms, or (iii) to favor (i.e., allocate with higher probability) the treatment arm that is currently faring better. These objectives can be fulfilled, respectively, by use of treatment‐adaptive randomization, covariate‐adaptive randomization, and outcome‐adaptive randomization. Treatment‐adaptive randomization can be implemented as a restricted randomization through randomly permuted blocks or as a dynamic method using a biased coin. Similarly, covariate‐adaptive randomization can use randomly permuted blocks within strata or minimization. Outcome‐adaptive randomization remains controversial because of it produces only modest gains in terms of total number of failures at the cost of increased complexity, a risk of accrual bias, and the potential for ethical concerns.
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