Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
Study NCT ID:
NCT04200950
Status:
WITHDRAWN
Last Update Posted:
2021-09-24
First Post:
2019-12-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial for the Early Identification of Acute Kidney Injury
Sponsor:
Dascena
Organization:
Study Overview
Official Title:
Randomized Controlled Trial for the Early Identification of Acute Kidney Injury Using Deep Recurrent Neural Nets
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No longer conducting this retrospective research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Previse is a novel, software-based clinical decision support (CDS) system that predicts acute kidney injury (AKI). Previse uses machine learning methods and information drawn from the electronic health record (EHR) to identify the early signs of acute kidney injury; by doing so before the clinical syndrome of AKI is fully developed, Previse can give clinicians the time to intervene with the goals of preventing further kidney damage, and decreasing the sequelae of AKI. It has been demonstrated in retrospective work that Previse can predict AKI with high accuracy at long prediction horizons, but the tool has yet to be validated in prospective settings; therefore, in this project, the clinical utility of Previse will be assessed through an individually randomized controlled multicenter trial.
Detailed Description:
The trial is designed as an individually randomized, controlled, and non-blinded multicenter prevention trial with a baseline period and a primary endpoint of proportion of patients meeting one or more criteria for the Major Adverse Kidney Events within 30 days (MAKE30) composite of death, new renal replacement therapy, or persistent creatinine elevation ≥ 200% of baseline, all censored at the first of hospital discharge or 30 days. The trial will evaluate the efficacy of a machine learning algorithm for AKI prediction, in approximately 8,574 patients aged ≥ 18 years admitted to one of three participating study hospitals. Individual patient randomization will be performed at the time of the alert with a 1:1 allocation ratio. Patients will be evaluated for inclusion in the trial upon admission, and will be automatically enrolled upon meeting inclusion criteria. Because data collection will be conducted through noninvasive procedures that are routinely employed in clinical practice, it will require a waiver of informed consent. Trial efficacy will be assessed at regularly scheduled study visits, and safety will be monitored on an ongoing basis for all patients. Safety will be assessed through the collection of adverse events, laboratory tests, vital signs, and physical examinations throughout the study. An independent Data Monitoring Committee (DMC) will be formed to assist in the periodic monitoring of safety, data quality, and integrity of study conduct. In addition, the DMC will review the interim efficacy analysis performed to determine whether the primary endpoint has been met. Total trial duration is expected to be approximately 12 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: