Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669548
Status:
RECRUITING
Last Update Posted:
2022-09-28
First Post:
2020-12-09
Brief Title:
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
Sponsor:
Potrero Medical
Organization:
Potrero Medical
Study Overview
Official Title:
Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis The Accuryn Registry
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Accuryn Registry Study is an open-ended global multi-center retrospective and prospective single-arm data collection study with an FDA cleared device The target population are cardiovascular surgery patients Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System
Detailed Description:
The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury AKI following cardiac surgical interventions
The secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population analyze what factors may contribute to the development of intra-abdominal hypertension IAH in this patient population and analyze associations of IAH with organ dysfunctions such as acute kidney injury and other clinical outcomes eg ICU length of stay required hemodialysis readmission
The secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population analyze what factors may contribute to the development of intra-abdominal hypertension IAH in this patient population and analyze associations of IAH with organ dysfunctions such as acute kidney injury and other clinical outcomes eg ICU length of stay required hemodialysis readmission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None