Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03574896 |
| Other study ID # |
S61388 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2018 |
| Est. completion date |
September 1, 2018 |
Study information
| Verified date |
May 2019 |
| Source |
KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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:
- upon admission: age, baseline serum creatinine (lowest value of the previous 3 months;
if not available, calculated using the Schwartz formula), surgical or medical category
(transplant surgery / cardiovascular surgery / abdominal or pelvic surgery / thoracic
surgery / other: medical, trauma, other surgery), planned admission (yes / no), history
of diabetes (yes / no), blood glucose, suspected sepsis (yes / no), and hemodynamic
support (none / mechanical / pharmacological / both);
- on the first morning after admission: serum creatinine (measured in the morning), APACHE
II score, blood lactate (worst value since admission), total bilirubin, and hours of ICU
stay;
- at 24h after admission: hourly urine output, doses of inotropes and vasopressors, and
continuous arterial blood pressure values.
Physicians predictions:
Physicians' predictions will be collected alternatively through interviews conducted
personally by one of the investigators or by means of a questionnaire compiled by the
physicians themselves. To parallel the timing of AKIpredictor, clinicians' predictions will
be gathered at three time-points:
- admission predictions: at the earliest after admission (up to 3h);
- morning predictions: on the first morning after admission, right before or after the
handoffs that take place between 8.30 and 9.00 AM;
- 24h predictions: at 24h after admission (up to 24h+3h).
Interviews to multiple physicians about the same patient in the same time frame will be
encouraged, as long as they are not influenced by one another (junior resident, senior
resident, staff member).
In every prediction, both a continuous (on a 0-100 % scale) and a binary (yes / no) estimate
of AKI risk will be inquired. A self-assessed degree of confidence about the prediction will
also be tracked (very confident / medium confident / not confident at all). The exact time at
which the human prediction is collected will be saved. Finally, data about the clinician
expressing the prediction will be tracked: age, gender, seniority (see above), years of ICU
experience.
Endpoint assessment The effective development of AKI will be diagnosed in agreement with the
2012 KDIGO guidelines [1]. To take into account AKI occurring outside the ICU where hourly
measurements of urine output are not recorded, only the creatinine criterion will be used.
Serum creatinine values will be collected from the electronic health record system KWS
(Klinisch WerkStation) each day for 7 days following ICU admission. This biochemical exam is
routinely performed on a daily basis in any hospitalized patient unless considered at low
risk for complications, and it is always required if there's suspicion of an acute renal
insult. For these reasons, potential missing creatinine values will be considered evidence of
an improving patient and absence of AKI for that day.
ICU discharge and eventual readmission will also be tracked for secondary analyses. The death
of the patient will also be recorded and included among the negative outcomes.
Assessment of efficacy The efficacy of both predictors will be evaluated with the
construction of ROC curves. Due to the lack of previous studies on the subject, a current
estimate of the accuracy of clinicians' prediction of AKI is not currently available.
Appropriate sample size calculations to obtain sufficient power are therefore not feasible at
the moment. Statistical analysis will be performed at the end of the data collection as
follows. A ROC curve will be plotted both for the computer-based AKIpredictor and the
continuous (%) estimate of AKI risk assessed by the clinicians at each of the three
time-points (upon admission, on day 1 and at 24 hours). The area under the curve (AUC) of
each plot will be calculated. The AUCs will then be compared in pairs by bootstrapping, and a
significance value of the comparison will be derived. Subgroup analysis will be performed
with the same approach.
Ethics and regulatory approvals:
The trial will be conducted in compliance with the principles of the Declaration of Helsinki
(current version) and the principles of good clinical practice. This protocol will be
submitted to the ethical committee of the UZ Leuven. Any eventual subsequent protocol
amendment will also be submitted to the ethical committee and Regulatory Authorities for
approval.
By virtue of its non-interventional nature and that all the data will be stored in anonymized
fashion, informed consent will not be required from the subjects if this is deemed
appropriate by the local Ethical Committee. The investigators shall treat all information and
data relating to the study as confidential and shall not disclose such information to any
third parties or use such information for any purpose other than the performance of the
study. The collection, processing and disclosure of personal data, such as patient health and
medical information is subject to compliance with applicable personal data protection and the
processing of personal data (Directive 95/46/EC and Belgian law of December 8, 1992 on the
Protection of the Privacy in relation to the Processing of Personal Data).
