Evaluation of Drainable Volume Measurements During VA-ELS

Heart Arrest Clinical Trial

Official title:

Evaluation of Drainable Volume Measurements and Their Usage for Predicting Optimal Cardiac Support in Patients Supported by Veno-arterial Extracorporeal Life Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02326506
• Other study ID #: NL49011.000.14
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2014
• Last updated: March 15, 2016
• Start date: September 2014

Study information

• Verified date: March 2016
• Source: Maastricht University Medical Center
• Contact: Martine E. Bol, MSc.
• Email: m.bol[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent of the relative(s) or legal representative(s)

• Supported by VA-ELS at the ICU

• >18 years

Exclusion Criteria:

• Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Arrest

Intervention

Device:
• VA-ELS pump speed variations
Small variations in the pump speed of the veno-arterial extracorporeal life support (VA-ELS) pump

Locations

Country	Name	City	State
Netherlands	Maastricht University Hospital	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Simons AP, Lancé 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. — View Citation

Simons AP, Reesink KD, Lancé 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. — View Citation

Simons AP, Reesink KD, Lancé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEE results		participants will be followed for the duration of the VA-ELS support, an expected average of 1 week	No