Identification of Major Adverse Kidney Events Within the Electronic Health Record

Semler, Matthew W.; Rice, Todd W.; Shaw, Andrew; Siew, Edward D.; Self, Wesley H.; Kumar, Avinash B.; Byrne, Daniel W.; Ehrenfeld, Jesse M.; Wanderer, Jonathan P.

doi:10.1007/s10916-016-0528-z

Cited by 61 publications

(74 citation statements)

References 32 publications

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“…12,16 These data included information on pre-enrollment renal function, demographic characteristics, diagnoses, predicted risk of inhospital death, orders for intravenous fluids and blood products, plasma electrolyte and creatinine values, receipt of renal-replacement therapy, and vital status at hospital discharge. Trial personnel who were unaware of group assignment performed manual chart reviews to confirm receipt of renal-replacement therapy and identify indications for new renal-replacement therapy.…”

Section: Methodsmentioning

confidence: 99%

“…The primary outcome was the proportion of patients who met one or more criteria for a major adverse kidney event within 30 days 16–20 — the composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value) — all censored at hospital discharge or 30 days after enrollment, whichever came first. The National Institute of Diabetes and Digestive and Kidney Diseases work group on clinical trials in acute kidney injury recommends the use of a major adverse kidney event within 30 days as a patient-centered outcome for phase 3 trials.…”

Section: Methodsmentioning

confidence: 99%

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Balanced Crystalloids versus Saline in Critically Ill Adults

Self²,

et al. 2018

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BACKGROUND Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes. METHODS In a pragmatic, cluster-randomized, multiple-crossover trial conducted in five intensive care units at an academic center, we assigned 15,802 adults to receive saline (0.9% sodium chloride) or balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A) according to the randomization of the unit to which they were admitted. The primary outcome was a major adverse kidney event within 30 days — a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) — all censored at hospital discharge or 30 days, whichever occurred first. RESULTS Among the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P = 0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P = 0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P = 0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P = 0.60). CONCLUSIONS Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction than the use of saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SMART-MED and SMART-SURG ClinicalTrials.gov numbers, NCT02444988 and NCT02547779.)

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Balanced Crystalloids versus Saline in Critically Ill Adults

Self²,

et al. 2018

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“…This pragmatic trial used data collected as part of routine clinical care and electronically extracted from the EHR (18). These data included: measures of prestudy renal function; demographic characteristics, admitting location and diagnosis, and severity of illness at enrollment; receipt of intravenous crystalloids, other fluids, and blood products; serum electrolyte and creatinine values; receipt of RRT, mechanical ventilation, and vasopressors; and vital status and serum creatinine at hospital discharge.…”

Section: Data Collectionmentioning

confidence: 99%

“…A detailed description of how variables were electronically collected and classified has been published previously (18) and is available in the online supplement. For all patients who received new RRT, study personnel performed manual chart review to confirm the absence of previous RRT and to identify indications for RRT present at the time of RRT initiation.…”

Section: Data Collectionmentioning

confidence: 99%

“…Enrollment immediately upon ICU admission, earlier than many trials of fluid management in critical illness, captured a peak period of fluid administration and risk for AKI development. Our study used MAKE30, a patient-centered outcome recommended for phase III trials by the National Institute of Diabetes and Digestive and Kidney Diseases workgroup on Clinical Trials in AKI (18,20,34). Finally, although previous studies have examined informatics-based interventions (35)(36)(37) or leveraged the EHR to facilitate aspects of trial conduct (37)(38)(39), to our knowledge, this is the first large, critical care clinical trial to be conducted entirely within the EHR.…”

Section: Original Articlementioning

confidence: 99%

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Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial

Semler

Wang

Byrne

et al. 2017

Am J Respir Crit Care Med

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Rationale: Saline is the intravenous fluid most commonly administered to critically ill adults, but it may be associated with acute kidney injury and death. Whether use of balanced crystalloids rather than saline affects patient outcomes remains unknown.Objectives: To pilot a cluster-randomized, multiple-crossover trial using software tools within the electronic health record to compare saline to balanced crystalloids.Methods: This was a cluster-randomized, multiple-crossover trial among 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015. The intravenous crystalloid used in the unit alternated monthly between saline (0.9% sodium chloride) and balanced crystalloids (lactated Ringer's solution or PlasmaLyte A). Enrollment, fluid delivery, and data collection were performed using software tools within the electronic health record. The primary outcome was the difference between study groups in the proportion of isotonic crystalloid administered that was saline. The secondary outcome was major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction.Measurements and Main Results: Patients assigned to saline (n = 454) and balanced crystalloids (n = 520) were similar at baseline and received similar volumes of crystalloid by 30 days (median [interquartile range]: 1,424 ml [500-3,377] vs. 1,617 ml [500-3,628]; P = 0.40). Saline made up a larger proportion of the isotonic crystalloid given in the saline group than in the balanced crystalloid group (91% vs. 21%; P , 0.001). MAKE30 did not differ between groups (24.7% vs. 24.6%; P = 0.98).Conclusions: An electronic health record-embedded, clusterrandomized, multiple-crossover trial comparing saline with balanced crystalloids can produce well-balanced study groups and separation in crystalloid receipt.Clinical trial registered with www.clinicaltrials.gov (NCT 02345486).

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Cefepime vs Piperacillin-Tazobactam in Adults Hospitalized With Acute Infection

Qian,

Casey,

Wright

et al. 2023

JAMA

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ImportanceCefepime and piperacillin-tazobactam are commonly administered to hospitalized adults for empirical treatment of infection. Although piperacillin-tazobactam has been hypothesized to cause acute kidney injury and cefepime has been hypothesized to cause neurological dysfunction, their comparative safety has not been evaluated in a randomized clinical trial.ObjectiveTo determine whether the choice between cefepime and piperacillin-tazobactam affects the risks of acute kidney injury or neurological dysfunction.Design, Setting, and ParticipantsThe Antibiotic Choice on Renal Outcomes (ACORN) randomized clinical trial compared cefepime vs piperacillin-tazobactam in adults for whom a clinician initiated an order for antipseudomonal antibiotics within 12 hours of presentation to the hospital in the emergency department or medical intensive care unit at an academic medical center in the US between November 10, 2021, and October 7, 2022. The final date of follow-up was November 4, 2022.InterventionsPatients were randomized in a 1:1 ratio to cefepime or piperacillin-tazobactam.Main Outcomes and MeasuresThe primary outcome was the highest stage of acute kidney injury or death by day 14, measured on a 5-level ordinal scale ranging from no acute kidney injury to death. The 2 secondary outcomes were the incidence of major adverse kidney events at day 14 and the number of days alive and free of delirium and coma within 14 days.ResultsThere were 2511 patients included in the primary analysis (median age, 58 years [IQR, 43-69 years]; 42.7% were female; 16.3% were Non-Hispanic Black; 5.4% were Hispanic; 94.7% were enrolled in the emergency department; and 77.2% were receiving vancomycin at enrollment). The highest stage of acute kidney injury or death was not significantly different between the cefepime group and the piperacillin-tazobactam group; there were 85 patients (n = 1214; 7.0%) in the cefepime group with stage 3 acute kidney injury and 92 (7.6%) who died vs 97 patients (n = 1297; 7.5%) in the piperacillin-tazobactam group with stage 3 acute kidney injury and 78 (6.0%) who died (odds ratio, 0.95 [95% CI, 0.80 to 1.13], P = .56). The incidence of major adverse kidney events at day 14 did not differ between groups (124 patients [10.2%] in the cefepime group vs 114 patients [8.8%] in the piperacillin-tazobactam group; absolute difference, 1.4% [95% CI, −1.0% to 3.8%]). Patients in the cefepime group experienced fewer days alive and free of delirium and coma within 14 days (mean [SD], 11.9 [4.6] days vs 12.2 [4.3] days in the piperacillin-tazobactam group; odds ratio, 0.79 [95% CI, 0.65 to 0.95]).Conclusions and RelevanceAmong hospitalized adults in this randomized clinical trial, treatment with piperacillin-tazobactam did not increase the incidence of acute kidney injury or death. Treatment with cefepime resulted in more neurological dysfunction.Trial RegistrationClinicalTrials.gov Identifier: NCT05094154

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Identification of Major Adverse Kidney Events Within the Electronic Health Record

Cited by 61 publications

References 32 publications

Balanced Crystalloids versus Saline in Critically Ill Adults

Balanced Crystalloids versus Saline in Critically Ill Adults

Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial

Cefepime vs Piperacillin-Tazobactam in Adults Hospitalized With Acute Infection

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