Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2025-12-17 @ 8:56 AM
Study NCT ID:
NCT04669548
Status:
None
Last Update Posted:
2022-09-28 00:00:00
First Post:
2020-12-09 00:00:00
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:
None
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 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 intervention(s).
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 (e.g. 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 (e.g. ICU length of stay, required hemodialysis, readmission).
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