Evaluation of Drainable Volume Measurements During VA-ELS

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02326506
Collaborator
(none)
10
1
1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: VA-ELS pump speed variations
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Drainable Volume Measurements and Their Usage for Predicting Optimal Cardiac Support in Patients Supported by Veno-arterial Extracorporeal Life Support
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pump speed variation

VA-ELS pump speed variations

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

Outcome Measures

Primary Outcome Measures

  1. TEE results [participants will be followed for the duration of the VA-ELS support, an expected average of 1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Hospital Maastricht Netherlands 6229 HX

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

  • Principal Investigator: Patrick W. Weerwind, Dr., Maastricht University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT02326506
Other Study ID Numbers:
  • NL49011.000.14
First Posted:
Dec 29, 2014
Last Update Posted:
Mar 16, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Maastricht University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2016