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Trial record 1 of 1 for:    NCT03574896
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Acute Kidney Injury Predictor Validation Study (AKIpredValid)

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ClinicalTrials.gov Identifier: NCT03574896
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Geert Meyfroidt, MD, PhD, KU Leuven

Brief Summary:

Purpose: To evaluate the performance of AKIpredictor, a computer-based algorithm that predicts the development of AKI in the 7 days following ICU admission, by comparing it with similar predictions made by attending physicians.

Primary objective: To compare the performances of AKIpredictor and physicians in predicting AKI stage 2 or 3 in the 7 days following ICU admission Secondary objective(s): To investigate the influence of the level of seniority of the physician on the accuracy of the predictions; feasibility of making predictions within a 3 hour window for physicians Trial Design: Monocentric, prospective, longitudinal, non-interventional Endpoints: Primary: comparing the area under the ROC curves of the AKIpredictor and physicians.

Secondary: estimation of PPV, NPV, sensitivity and specificity of both predictors at different thresholds; evaluation of alternative negative endpoints (ICU readmission after discharge, death); subgroup analyses.

Sample Size: This is a pilot study. Sample size calculations to obtain sufficient power are not feasible due to lack of previous studies. The investigation will be conducted with a preset end time on June 30th. The investigators expect to include approximately 150 patients.

Summary of eligibility criteria: All adult patients admitted to UZ Leuven's surgical ICU in the period of the study, with the exclusion of those with end-stage renal disease or AKI already present at the time of admission


Condition or disease Intervention/treatment
Critical Illness Acute Kidney Injury Other: Computer model predictions of acute kidney injury

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Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Validation of the AKIpredictor Through Comparison With Predictions of Acute Kidney Injury by ICU Physicians
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : September 1, 2018

Intervention Details:
  • Other: Computer model predictions of acute kidney injury
    Comparison of the performances of AKIpredictor and physicians in predicting AKI stage 2 or 3 in the 7 days following ICU admission


Primary Outcome Measures :
  1. AUROC comparison [ Time Frame: 1 week ]
    Comparison of the area under the receiver-operator characteristic (ROC) curves between the predictions made by the AKIpredictor and the ones made by ICU physicians, to predict AKI 2-3.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients admitted to UZ Leuven's surgical ICU in the period of the study, with the exclusion of those with end-stage renal disease or AKI already present at the time of admission
Criteria

Inclusion Criteria:

  • All adult patients admitted to UZ Leuven's surgical ICU in the period of the study

Exclusion Criteria:

  • Patients with end-stage renal disease or AKI already present at the time of 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): NCT03574896


Locations
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Belgium
Geert Meyfroidt
Kessel-Lo, Belgium, 3010
Sponsors and Collaborators
Geert Meyfroidt, MD, PhD
Investigators
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Principal Investigator: Geert Meyfroidt, MD, Phd KU Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Geert Meyfroidt, MD, PhD, Associate Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT03574896    
Other Study ID Numbers: S61388
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
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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Acute Kidney Injury
Critical Illness
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes