Heart ArrestNCT02326506
Evaluation of Drainable Volume Measurements During VA-ELS
A study testing VA-ELS pump speed variations in people with Heart Arrest, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- VA-ELS pump speed variations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of the relative(s) or legal representative(s)
- Supported by VA-ELS at the ICU
- >18 years
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Martine E. Bol, MSc. contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Hospital
Maastricht, 6229 HX
About this study
Official title: 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
- Conditions
- Heart Arrest
- Being tested
- VA-ELS pump speed variations
- Keywords
- Extracorporeal Membrane Oxygenation, Cardiopulmonary Bypass
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA-ELS pump speed variationsDevice
Small variations in the pump speed of the veno-arterial extracorporeal life support (VA-ELS) pump
| Study group | Role | What they receive |
|---|---|---|
| Pump speed variation | Experimental | VA-ELS pump speed variations Receives: Device: VA-ELS pump speed variations |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEE results
Measured: participants will be followed for the duration of the VA-ELS support, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick W. Weerwind, Dr., Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326506
- Sponsor's protocol ID
- NL49011.000.14
- Status last verified
- Mar 2016
- First submitted
- 8 Oct 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20118166Simons 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.
PubMed 19411180Simons 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.
PubMed 20423482
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Drainable Volume Measurements and Their Usage for Predicting Optimal Cardiac Support in Patients Supported by Veno-arterial Extracorporeal Life Support
- ClinicalTrials.gov ID
- NCT02326506
- Acronym / sponsor ID
- NL49011.000.14
- Conditions
- Heart Arrest
- Keywords
- Extracorporeal Membrane Oxygenation, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pump speed variation | Experimental | Device: VA-ELS pump speed variationsVA-ELS pump speed variations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent of the relative(s) or legal representative(s)
- Supported by VA-ELS at the ICU
- >18 years
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA-ELS pump speed variationsSmall variations in the pump speed of the veno-arterial extracorporeal life support (VA-ELS) pump | Device | Pump speed variation |
Primary outcome
TEE results
Time frame: participants will be followed for the duration of the VA-ELS support, an expected average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 20118166Simons 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.
- Background: PubMed 19411180Simons 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.
- Background: PubMed 20423482Simons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine E. Bol, MSc. contact
Patrick W. Weerwind, Dr. principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA-ELS pump speed variations in people with Heart Arrest, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine E. Bol, MSc. (m.bol@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEE results (time frame: participants will be followed for the duration of the VA-ELS support, an expected average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326506, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.