Evaluation of Drainable Volume Measurements During VA-ELS

March 15, 2016 updated by: Maastricht University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Maastricht University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TEE results
Time Frame: participants will be followed for the duration of the VA-ELS support, an expected average of 1 week
participants will be followed for the duration of the VA-ELS support, an expected average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 29, 2014

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49011.000.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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