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Trial record 21 of 221 for:    Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT03590028
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Early Nephrology Consult (ENC) Other: Standard of Care (SOC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury: A Randomized Trial of an Early Standardized, Personalized Nephrology Intervention
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Arm Intervention/treatment
Experimental: Early Nephrology Consult (ENC)
The ENC will be a structured consultative note that will provide detailed recommendations around issues such as Differential Diagnosis, Drug Dosing and Volume Status. The research ENC will have a daily follow-up with documented recommendations.
Other: Early Nephrology Consult (ENC)
The electronic risk prediction algorithm (ESTOP-AKI) will interface with electronic medical data to determine the likelihood for the patient to develop AKI. Early Nephrology Consult (ENC) will be implemented. A nephrologist will assess the subject and consult with their care team to advise a treatment plan during the hospitalization.

Active Comparator: Standard of Care (SOC)
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
Other: Standard of Care (SOC)
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.




Primary Outcome Measures :
  1. Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval [ Time Frame: 7-day interval ]
    The primary endpoint of interest, change in serum creatinine (SCr), is the peak change from study entry in SCr level over a 7-day interval. The change in SCr is defined as the maximal change in creatinine over this interval, and aim to detect a clinical difference in change in SCr between the SOC and ENC treatment groups.


Other Outcome Measures:
  1. Differences by treatment group in the proportion by percent and time in days to specified medical events. [ Time Frame: 3 months ]
    The differences will be measured by treatment group in the proportion and time to event of patients who a) develop > Stage 2 AKI, b) require renal replacement therapy (RRT), c) undergo intensive care unit (ICU) transfer, and/or d) require non-research nephrology consult.

  2. Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital. [ Time Frame: 3 months ]
    The differences will be measured by treatment group in the proportion by percent and time in days of LOS in the hospital.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years old
  2. Initial ESTOP AKI score ≥0.12 within the last 8 hours.

Exclusion Criteria:

  1. Voluntary refusal or missing written consent of the patient / legal representative.
  2. Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
  3. Patients without a measured serum creatinine value during their inpatient stay.
  4. Patients with a creatinine >4.0 mg/dl at the time of admission or available in the electronic health record (EHR) from the last 6 months.
  5. Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
  6. Patients with prior renal consultation during their admission.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590028


Contacts
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Contact: Sharon Trevino, RN 773-702-6201 strevino@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Sharon Trevino         
Contact       strevino@bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jay Koyner, MD University of Chicago Medicine

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03590028     History of Changes
Other Study ID Numbers: IRB17-1081
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases