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
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|
|Study Type :||Observational|
|Actual Enrollment :||252 participants|
|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|
- 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
- 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.
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
|Kessel-Lo, Belgium, 3010|
|Principal Investigator:||Geert Meyfroidt, MD, Phd||KU Leuven|