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Evaluation of Drainable Volume Measurements During VA-ELS

Primary Purpose

Heart Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
VA-ELS pump speed variations
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Arrest focused on measuring Extracorporeal Membrane Oxygenation, Cardiopulmonary Bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pump speed variation

Arm Description

VA-ELS pump speed variations

Outcomes

Primary Outcome Measures

TEE results

Secondary Outcome Measures

Full Information

First Posted
October 8, 2014
Last Updated
March 15, 2016
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02326506
Brief Title
Evaluation of Drainable Volume Measurements During VA-ELS
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest
Keywords
Extracorporeal Membrane Oxygenation, Cardiopulmonary Bypass

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pump speed variation
Arm Type
Experimental
Arm Description
VA-ELS pump speed variations
Intervention Type
Device
Intervention Name(s)
VA-ELS pump speed variations
Intervention Description
Small variations in the pump speed of the veno-arterial extracorporeal life support (VA-ELS) pump
Primary Outcome Measure Information:
Title
TEE results
Time Frame
participants will be followed for the duration of the VA-ELS support, an expected average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martine E. Bol, MSc.
Email
m.bol@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick W. Weerwind, Dr.
Organizational Affiliation
Maastricht University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Hospital
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
20118166
Citation
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.
Results Reference
background
PubMed Identifier
19411180
Citation
Simons 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.
Results Reference
background
PubMed Identifier
20423482
Citation
Simons 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.
Results Reference
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Evaluation of Drainable Volume Measurements During VA-ELS

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