Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-01 @ 5:01 PM
Study NCT ID:
NCT02326506
Status:
UNKNOWN
Last Update Posted:
2016-03-16
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Drainable Volume Measurements During VA-ELS
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
Evaluation of Drainable Volume Measurements and Their Usage for Predicting Optimal Cardiac Support in Patients Supported by Veno-arterial Extracorporeal Life Support
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
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:
Veno-arterial extracorporeal life support (VA-ELS) is used to support patients with acute cardiac failure. In that context, sufficient drainable venous volume is crucial for reliable and adequate support. To date, no reliable measurement method exists to monitor drainable volume adequately. Furthermore, it is still unresolved how to diagnose adequate cardiac recovery.
Previous (pre)clinical studies showed that the calculation of the dynamic filling index may provide a valuable parameter to monitor the drainable volume in patients supported by VAELS. In addition, a case report showed that measurement of the dynamic filling index could successfully be used to estimate cardiac recovery in a single patient supported by VA-ELS in the ICU.
This study will assess the dynamic filling index as a representation for drainable volume and cardiac recovery using standard recorded perfusion data in patients supported by VA-ELS
Previous (pre)clinical studies showed that the calculation of the dynamic filling index may provide a valuable parameter to monitor the drainable volume in patients supported by VAELS. In addition, a case report showed that measurement of the dynamic filling index could successfully be used to estimate cardiac recovery in a single patient supported by VA-ELS in the ICU.
This study will assess the dynamic filling index as a representation for drainable volume and cardiac recovery using standard recorded perfusion data in patients supported by VA-ELS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: