Evaluation of Drainable Volume Measurements During VA-ELS
1 other identifier
interventional
10
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedMarch 16, 2016
March 1, 2016
2.3 years
October 8, 2014
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TEE results
participants will be followed for the duration of the VA-ELS support, an expected average of 1 week
Study Arms (1)
Pump speed variation
EXPERIMENTALVA-ELS pump speed variations
Interventions
Small variations in the pump speed of the veno-arterial extracorporeal life support (VA-ELS) pump
Eligibility Criteria
You may qualify if:
- Written informed consent of the relative(s) or legal representative(s)
- Supported by VA-ELS at the ICU
- \>18 years
You may not qualify if:
- \- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Hospital
Maastricht, 6229 HX, Netherlands
Related Publications (3)
Simons AP, Reesink KD, Lance MD, van der Nagel T, van der Veen FH, Weerwind PW, Maessen JG. Reserve-driven flow control for extracorporeal life support: proof of principle. Perfusion. 2010 Jan;25(1):25-9. doi: 10.1177/0267659109360284. Epub 2010 Jan 29.
PMID: 20118166BACKGROUNDSimons AP, Reesink KD, Lance MD, van der Veen FH, de Jong DS, Weerwind PW, Maessen JG. Dynamic filling index: a novel parameter to monitor circulatory filling during minimized extracorporeal bypass. Eur J Cardiothorac Surg. 2009 Aug;36(2):330-4. doi: 10.1016/j.ejcts.2009.03.045. Epub 2009 May 2.
PMID: 19411180BACKGROUNDSimons AP, Lance MD, Reesink KD, van der Veen FH, Weerwind PW, Maessen JG. Quantitative assessment of cardiac load-responsiveness during extracorporeal life support: case and rationale. J Cardiothorac Surg. 2010 Apr 27;5:30. doi: 10.1186/1749-8090-5-30.
PMID: 20423482BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick W. Weerwind, Dr.
Maastricht University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2014
First Posted
December 29, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2016
Last Updated
March 16, 2016
Record last verified: 2016-03