NCT01862419

Brief Summary

This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,393

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 25, 2015

Completed
Last Updated

March 25, 2015

Status Verified

April 1, 2014

Enrollment Period

7 months

First QC Date

May 16, 2013

Results QC Date

March 13, 2015

Last Update Submit

March 13, 2015

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

  • Dialysis Within 7 Days

    This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis.

    From start of AKI to 7 days later

  • Death

    7 days of randomization

  • Relative Maximum Change in Creatinine

    7 days of randomization

Study Arms (2)

Alert

EXPERIMENTAL

Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.

Other: Alert

Usual Care

NO INTERVENTION

Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.

Interventions

AlertOTHER
Also known as: Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \>=18 years
  • Admitted to the Hospital of the University of Pennsylvania for greater than 24 hours.

You may not qualify if:

  • Dialysis order within 24 hours of admission
  • Dialysis order prior to AKI onset
  • Initial creatinine \>=4.0mg/dl
  • Prior admission in which patient was randomized.
  • Nephrectomy during the admission
  • Admission to hospice service
  • Admission to observation status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Phiadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.

    PMID: 25726515DERIVED

  • Wilson FP, Reese PP, Shashaty MG, Ellenberg SS, Gitelman Y, Bansal AD, Urbani R, Feldman HI, Fuchs B. A trial of in-hospital, electronic alerts for acute kidney injury: design and rationale. Clin Trials. 2014 Oct;11(5):521-9. doi: 10.1177/1740774514542619. Epub 2014 Jul 14.

    PMID: 25023200DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Francis Perry Wilson, MD MSCE
Organization
Yale University School of Medicine
francis.p.wilson@yale.edu
2037371704

Study Officials

  • Barry Fuchs, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Francis P Wilson, MD MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 24, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 25, 2015

Results First Posted

March 25, 2015

Record last verified: 2014-04

Locations

US(1)