Prospective Validation of the AKIpredictor Through Comparison With Predictions of Acute Kidney Injury by ICU Physicians
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- AUROC comparison
Study Overview
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
Detailed Description
Inclusion and exclusion criteria:
All adult patients admitted to the UZ Leuven's ICU after the approval of the study by the local Ethical Committee and before June 30th 2018 will be included in the study. The only exclusion criteria will be the presence of end-stage renal disease before or of AKI on ICU admission.
Computer predictions:
Elements from laboratory reports, clinical history and physiological monitoring will be used both by clinicians and by the computer algorithm to estimate the risk of AKI. Such measurements are part of the routine standard care in the ICU: no additional exam will be required for this study. These values are regularly stored in the electronic health care system (KWS, Klinisch Werkstation and iMDsoft's MetaVision). They will be retrieved in read-only mode when needed for formulating the predictions. The retrieval will take place regularly on a weekly basis in order to limit the amount of time that patients' identification data will be stored for the study.
In detail, the following parameters will be used by the computer model:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Geert Meyfroidt, MD, PhD
Associate Professor
KU Leuven