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Completed

NCT Number: NCT02753751

Optimizing Electronic Alerts for Acute Kidney Injury

This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.

The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.

This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult ≥ 18 years admitted to a participating study hospital
  • Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).

Exclusion criteria

  • ESKD diagnosis code
  • Dialysis order prior to AKI onset
  • Initial creatinine >=4.0mg/dl
  • Prior admission in which patient was randomized.
  • Admission to hospice service or comfort measures only order
  • Kidney transplant within 6 months

Treatment and study plan

AKI Alert

Other

Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.

Primary outcomes

  1. Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death

    Time frame: 14 days from randomization

    Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization.

    Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included.

    Mortality will be determined from hospital administrative records.

Secondary outcomes

  1. Mortality

    Time frame: 14 days from randomization

    14-day or inpatient mortality

  2. Dialysis

    Time frame: 14 days from randomization

    14-day, inpatient, or discharged on dialysis

  3. AKI Progression

    Time frame: 14 days from randomization

    Percent of patients who progress to stage 2 AKI and to stage 3 AKI

  4. AKI Duration

    Time frame: 14 days from randomization

    Number of participants with AKI duration of <2 days, 2-<days, and 7+ days (Aki duration defined as time in days between AKI onset and AKI cessation during index hospitalization)

  5. Readmission Rate

    Time frame: 30 days from randomization

    30 day readmission rate

  6. Index Hospitalization Cost

    Time frame: Index hospitalization through discharge, up to one year

    Cost of index hospitalization, measured in direct and total costs. Direct costs reflect those associated with direct patient contact involving billable services (for example lab, nursing costs, and supplies). Total costs also include non-billable support services such as medical records, human resources, accounting, support staff, utilities and dietary costs.

  7. Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization

    Time frame: 24 hours from randomization to discharge, up to one year

    Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV contrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization.

    Each metric above is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.

  8. Number of Subjects With Chart Documentation of AKI

    Time frame: Index hospitalization

    Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2016
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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