Evaluation of Drainable Volume Measurements During VA-ELS

NCT ID: NCT02326506

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Heart Arrest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pump speed variation

VA-ELS pump speed variations

Group Type EXPERIMENTAL

VA-ELS pump speed variations

Intervention Type DEVICE

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

Interventions

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VA-ELS pump speed variations

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick W. Weerwind, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital

Locations

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Maastricht University Hospital

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Martine E. Bol, MSc.

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 20118166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19411180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20423482 (View on PubMed)

Other Identifiers

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NL49011.000.14

Identifier Type: -

Identifier Source: org_study_id

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