F Perry Wilson1, Michael Shashaty2, Jeffrey Testani3, Iram Aqeel4, Yuliya Borovskiy5, Susan S Ellenberg6, Harold I Feldman7, Hilda Fernandez8, Yevgeniy Gitelman5, Jennie Lin5, Dan Negoianu5, Chirag R Parikh3, Peter P Reese2, Richard Urbani9, Barry Fuchs5. 1. Yale University School of Medicine, Program of Applied Translational Research, New Haven, CT, USA. Electronic address: francis.p.wilson@yale.edu. 2. Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics at the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. 3. Yale University School of Medicine, Program of Applied Translational Research, New Haven, CT, USA. 4. Nephrology Associates, Teaneck, NJ, USA. 5. Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. 6. Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics at the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. 7. Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics at the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. 8. Columbia University College of Physicians and Surgeons, New York, NY, USA. 9. Department of Information Services, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Abstract
BACKGROUND:Acute kidney injury often goes unrecognised in its early stages when effective treatment options might be available. We aimed to determine whether an automated electronic alert for acute kidney injury would reduce the severity of such injury and improve clinical outcomes in patients in hospital. METHODS: In this investigator-masked, parallel-group, randomised controlled trial, patients were recruited from the hospital of the University of Pennsylvania in Philadelphia, PA, USA. Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria. Exclusion criteria were initial hospital creatinine 4·0 mg/dL (to convert to μmol/L, multiply by 88·4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease. Patients were randomly assigned (1:1) via a computer-generated sequence to receive an acute kidney injury alert (a text-based alert sent to the covering provider and unit pharmacist indicating new acute kidney injury) or usual care, stratified by medical versus surgical admission and intensive care unit versus non-intensive care unit location in blocks of 4-8 participants. The primary outcome was a composite of relative maximum change in creatinine, dialysis, and death at 7 days after randomisation. All analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01862419. FINDINGS:Between Sept 17, 2013, and April 14, 2014, 23,664 patients were screened. 1201 eligible participants were assigned to the acute kidney injury alert group and 1192 were assigned to the usual care group. Composite relative maximum change in creatinine, dialysis, and death at 7 days did not differ between the alert group and the usual care group (p=0·88), or within any of the four randomisation strata (all p>0·05). At 7 days after randomisation, median maximum relative change in creatinine concentrations was 0·0% (IQR 0·0-18·4) in the alert group and 0·6% (0·0-17·5) in the usual care group (p=0·81); 87 (7·2%) patients in the alert group and 70 (5·9%) patients in usual care group had received dialysis (odds ratio 1·25 [95% CI 0·90-1·74]; p=0·18); and 71 (5·9%) patients in the alert group and 61 (5·1%) patients in the usual care group had died (1·16 [0·81-1·68]; p=0·40). INTERPRETATION: An electronic alert system for acute kidney injury did not improve clinical outcomes among patients in hospital. FUNDING: Penn Center for Healthcare Improvement and Patient Safety.
RCT Entities:
BACKGROUND:Acute kidney injury often goes unrecognised in its early stages when effective treatment options might be available. We aimed to determine whether an automated electronic alert for acute kidney injury would reduce the severity of such injury and improve clinical outcomes in patients in hospital. METHODS: In this investigator-masked, parallel-group, randomised controlled trial, patients were recruited from the hospital of the University of Pennsylvania in Philadelphia, PA, USA. Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria. Exclusion criteria were initial hospital creatinine 4·0 mg/dL (to convert to μmol/L, multiply by 88·4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease. Patients were randomly assigned (1:1) via a computer-generated sequence to receive an acute kidney injury alert (a text-based alert sent to the covering provider and unit pharmacist indicating new acute kidney injury) or usual care, stratified by medical versus surgical admission and intensive care unit versus non-intensive care unit location in blocks of 4-8 participants. The primary outcome was a composite of relative maximum change in creatinine, dialysis, and death at 7 days after randomisation. All analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01862419. FINDINGS: Between Sept 17, 2013, and April 14, 2014, 23,664 patients were screened. 1201 eligible participants were assigned to the acute kidney injury alert group and 1192 were assigned to the usual care group. Composite relative maximum change in creatinine, dialysis, and death at 7 days did not differ between the alert group and the usual care group (p=0·88), or within any of the four randomisation strata (all p>0·05). At 7 days after randomisation, median maximum relative change in creatinine concentrations was 0·0% (IQR 0·0-18·4) in the alert group and 0·6% (0·0-17·5) in the usual care group (p=0·81); 87 (7·2%) patients in the alert group and 70 (5·9%) patients in usual care group had received dialysis (odds ratio 1·25 [95% CI 0·90-1·74]; p=0·18); and 71 (5·9%) patients in the alert group and 61 (5·1%) patients in the usual care group had died (1·16 [0·81-1·68]; p=0·40). INTERPRETATION: An electronic alert system for acute kidney injury did not improve clinical outcomes among patients in hospital. FUNDING: Penn Center for Healthcare Improvement and Patient Safety.
Authors: Brian L Strom; Rita Schinnar; Faten Aberra; Warren Bilker; Sean Hennessy; Charles E Leonard; Eric Pifer Journal: Arch Intern Med Date: 2010-09-27
Authors: Morgan E Grams; Michelle M Estrella; Josef Coresh; Roy G Brower; Kathleen D Liu Journal: Clin J Am Soc Nephrol Date: 2011-03-10 Impact factor: 8.237
Authors: Philippe Lachance; Pierre-Marc Villeneuve; Oleksa G Rewa; Francis P Wilson; Nicholas M Selby; Robin M Featherstone; Sean M Bagshaw Journal: Nephrol Dial Transplant Date: 2017-02-01 Impact factor: 5.992
Authors: Michael Haase; Andreas Kribben; Walter Zidek; Jürgen Floege; Christian Albert; Berend Isermann; Bernt-Peter Robra; Anja Haase-Fielitz Journal: Dtsch Arztebl Int Date: 2017-01-09 Impact factor: 5.594
Authors: Nicholas M Selby; Anna Casula; Laura Lamming; John Stoves; Yohan Samarasinghe; Andrew J Lewington; Russell Roberts; Nikunj Shah; Melanie Johnson; Natalie Jackson; Carol Jones; Erik Lenguerrand; Eileen McDonach; Richard J Fluck; Mohammed A Mohammed; Fergus J Caskey Journal: J Am Soc Nephrol Date: 2019-02-21 Impact factor: 10.121