Evidence map›Paper›PMID 25023200›Full record

Trial reportClinical trials (London, England)2014

A trial of in-hospital, electronic alerts for acute kidney injury: design and rationale.

Francis Perry Wilson, Peter P Reese, Michael Gs Shashaty, Susan S Ellenberg, Yevgeniy Gitelman, Amar D Bansal, Richard Urbani, Harold I Feldman, Barry Fuchs

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical trials (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. eHealth interventions for people with chronic kidney disease.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Improvement of drug prescribing in acute kidney injury with a nephrotoxic drug alert system.European journal of hospital pharmacy : science and practice · 2019
    Article
  7. Article
  8. False-Positive Rate of AKI Using Consensus Creatinine-Based Criteria.Clinical journal of the American Society of Nephrology : CJASN · 2015
    Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Francis Perry WilsonRenal, Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA francisw@mail.med.upenn.edu.
Peter P ReeseRenal, Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.
Michael Gs ShashatyCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Pulmonary, Allergy and Critical Care Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Susan S EllenbergCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
Yevgeniy GitelmanRenal, Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Amar D BansalRenal, Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Richard UrbaniDepartment of Information Services, University of Pennsylvania, Philadelphia PA, USA.
Harold I FeldmanRenal, Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.
Barry FuchsPulmonary, Allergy and Critical Care Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.

Funding

Mediators & prognostic value of muscle mass & function in chronic kidney diseaseK23DK097201 · NIDDK · YALE UNIVERSITY · PI WILSON, FRANCIS PERRY · 2013 to 2017
$916k
Acute Adipose Inflammation as a Contributor to Acute Kidney Injury After TraumaK23DK097307 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI SHASHATY, MICHAEL G. S. · 2013 to 2016
$626k
NIDDK NIH HHS DK097201NIDDK NIH HHS DK097307NIDDK NIH HHS K23 DK097201NIDDK NIH HHS K23 DK097307
6 · The paper itself

Abstract

backgroundAcute kidney injury is common in hospitalized patients, increases morbidity and mortality, and is under-recognized. To improve provider recognition, we previously developed an electronic alert system for acute kidney injury. To test the hypothesis that this electronic acute kidney injury alert could improve patient outcome, we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients. The study design presented several methodologic, ethical, and statistical challenges. PURPOSE: To highlight the challenges faced and the solutions employed in the design and implementation of a clinical trial to determine whether the provision of an early electronic alert for acute kidney injury would improve outcomes in hospitalized patients. Challenges included how to randomize the delivery of the alert system and the ethical framework for waiving informed consent. Other methodologic challenges included the selection and statistical evaluation of our study outcome, a ranked-composite of a continuous covariate (creatinine) and two dichotomous outcomes (dialysis and death), and the use of the medical record as a source of trial data.

methodsWe have designed a randomized trial to assess the effectiveness of an electronic alert system for acute kidney injury. With broad inclusion criteria, and a waiver of informed consent, we enroll and randomize virtually every patient with acute kidney injury in our hospital.

resultsAs of 31 March 2014, we have enrolled 2373 patients of 2400 targeted. Pre-alert data demonstrated a strong association between severity of acute kidney injury and inpatient mortality with a range of 6.4% in those with mild, stage 1 acute kidney injury, to 29% among those with stage 3 acute kidney injury (p < 0.001). We judged that informed consent would undermine the scientific validity of the study and present harms that are out of proportion to the very low risk intervention.

conclusionOur study demonstrates the feasibility of designing an ethical randomized controlled trial of an early electronic alert for acute kidney injury without obtaining informed consent from individual participants. Our study outcome may serve as a model for other studies of acute kidney injury, insofar as our paradigm accounts for the effect that early death and dialysis have on assessment of acute kidney injury severity as defined by maximum achieved serum creatinine.

Indexed as

Electronic Health RecordsHospitalizationAcute Kidney InjuryCreatinineDouble-Blind MethodElectronic Data ProcessingHumansOutcome Assessment, Health CareCreatinineAcute kidney injuryacute renal failurecomposite outcomesethicswaiver of informed consent

Identifiers

PMID25023200
PMCPMC4156885

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.