Comparison of Availability for Prediction of Volume ResponsivenessNCT01412970
Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography
A study testing volume loading in people with Comparison of Availability for Prediction of Volume Responsiveness and Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparison of Availability for Prediction of Volume Responsiveness, Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation
- What is being tested?
- volume loading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Mar 2017
- 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
- Age >18 years
- Indication for advanced invasive hemodynamic monitoring due to operative procedure
- Necessity of postoperative invasive ventilation
Who cannot join
- Age <18 years
- known affections cardiac function
- presence of cardiac arrhythmias
- contraindication for placement of central venous or femoral artery catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Measurement of Central Hemodynamics and Heart-lung Interactions by Electrical Impedance Tomography
The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.
Read the detailed description
The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.
- Conditions
- Comparison of Availability for Prediction of Volume Responsiveness, Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation
- Being tested
- volume loading
- Keywords
- hemodynamic monitoring, volume responsiveness, electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume loadingOther
volume loading according to functional parameters of cardiac preload, i.e. stroke volume variations measured by arterial pulse contour analysis
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | comparison of ability to predict volume responsiveness and precision of measurement of stroke volume variation assessed by electrical impedance tomography in comparison to clinically established invasive hemodynamic monitoring devices, i.e. arterial pulse contour analysis during volume loading procedures Receives: Other: volume loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to assess volume responsiveness by electrical impedance tomography
Assessment of volume responsiveness by electrical impedance tomography in mechanically ventilated patients by measurement of stroke volume variations under stepwise volume loading
Measured: within 3 hrs after surgical procedure
Secondary outcomes (1)
precision of estimation of non invasive measurement of stroke volume variation
precision of estimation of non invasive measurement of stroke volume variation by electrical impedance tomography in comparison to clinically established, invasive advanced hemodynamic monitoring devices
Measured: within 3 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startJul 2016 (estimated)
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Why it stopped: received no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparison of Availability for Prediction of Volume ResponsivenessStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement, Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Daniel A Reuter, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412970
- Sponsor's protocol ID
- DFG3171_2-1
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2011
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Maisch S, Bohm SH, Sola J, Goepfert MS, Kubitz JC, Richter HP, Ridder J, Goetz AE, Reuter DA. Heart-lung interactions measured by electrical impedance tomography. Crit Care Med. 2011 Sep;39(9):2173-6. doi: 10.1097/CCM.0b013e3182227e65.
PubMed 21666450
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurement of Central Hemodynamics and Heart-lung Interactions by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT01412970
- Acronym / sponsor ID
- DFG3171_2-1
- Conditions
- Comparison of Availability for Prediction of Volume Responsiveness, Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation
- Keywords
- hemodynamic monitoring, volume responsiveness, electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: received no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement, Oregon Health and Science University
- Study start
- Jul 2016 (estimated)
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 9 Aug 2011 (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.
The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.
Detailed description
The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Other: volume loadingcomparison of ability to predict volume responsiveness and precision of measurement of stroke volume variation assessed by electrical impedance tomography in comparison to clinically established invasive hemodynamic monitoring devices, i.e. arterial pulse contour analysis during volume loading procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Indication for advanced invasive hemodynamic monitoring due to operative procedure
- Necessity of postoperative invasive ventilation
Key exclusion criteria (4 listed)
- Age <18 years
- known affections cardiac function
- presence of cardiac arrhythmias
- contraindication for placement of central venous or femoral artery catheter
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 |
|---|---|---|
| volume loadingvolume loading according to functional parameters of cardiac preload, i.e. stroke volume variations measured by arterial pulse contour analysis | Other | study group |
Primary outcome
Ability to assess volume responsiveness by electrical impedance tomography
Time frame: within 3 hrs after surgical procedure
Assessment of volume responsiveness by electrical impedance tomography in mechanically ventilated patients by measurement of stroke volume variations under stepwise volume loading
1 secondary outcome
precision of estimation of non invasive measurement of stroke volume variation
Time frame: within 3 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 21666450Maisch S, Bohm SH, Sola J, Goepfert MS, Kubitz JC, Richter HP, Ridder J, Goetz AE, Reuter DA. Heart-lung interactions measured by electrical impedance tomography. Crit Care Med. 2011 Sep;39(9):2173-6. doi: 10.1097/CCM.0b013e3182227e65.
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.
Daniel A Reuter, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing volume loading in people with Comparison of Availability for Prediction of Volume Responsiveness and Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 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: withdrawn, as of the sponsor's last update on 30 Aug 2022. 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 Germany. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to assess volume responsiveness by electrical impedance tomography (time frame: within 3 hrs after surgical procedure). 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 NCT01412970, which also lists 1 linked publication.
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 30 Aug 2022.