Fluid ResponsivenessNCT02520037
Fluid Responsiveness Prediction Using Extra Systoles
An observational study of Fluid Responsiveness, run by University of Aarhus at 1 site in Denmark.
Trial summary
Fluids are generally administered to patients in order to improve circulation. However, fluids do not always improve circulation and fluids have side effects. Unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jun 2015to 1 Nov 2016
- Phase
- Observational
- 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
Study population: Critically ill patients admitted to a University Hospital intensive care unit
Who may be able to join
- Patients scheduled for a 500 ml volume expansion
- Patients without atrial fibrillation
- Patients equipped with ECG, arterial pressure and non-invasive cardiac output monitoring
Who cannot join
- Changes in anesthetic, vasoactive or inotropic drugs during the study period (30 minutes before fluid infusion initiation to end of fluid infusion).
- Changes in positive end-expiratory pressure the study period
- Changes in bed positioning the study period
- Infusion time with crystalloids exceeding 30 minutes
- Infusion time with colloids exceeding 75 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients
Fluids are generally administered to patients in order to improve circulation. However, fluids do not always improve circulation and fluids have side effects. Unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. it is difficult to predict fluid responsiveness The overall aim of this observational study is to investigate if analysis of spontaneously occuring extra systoles can give the answer: The second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has experienced the compensatory pause, i.e. this beat is associated with increased filling time and in turn associated with increased filling. As such, the post ectopic beat shows how the heart responds to increased filling. Therefore, the hypothesis of this study is that the hemodynamic response to the increased filling at the post ectopic beat (compared with sinus beats) can predict fluid responsiveness
- Conditions
- Fluid Responsiveness
- Keywords
- Fluid responsiveness, Volume responsiveness, Hemodynamics
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stroke volume (SV) following fluid administration. A positive fluid response is defined as a 15% or more increase in SV
A positive fluid response is defined as a 15% or more increase in SV. From the arterial pressure curve, post ectopic changes (comparing with 10 preceding sinus beats) in systolic blood pressure and pre-ejection period will be derived and used to predict the fluid response. Time frame used is the 30 minutes prior to the volume expansion (from t = -30 min to t = 0 min)
Measured: Change in SV from immediately before fluid infusion (t=0 min) to immediately after fluid administration (t < 30 min for crystalloid infusions; t < 75 min for colloid infusions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study start15 Jun 2015
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520037
- Sponsor's protocol ID
- University of Aarhus
- Status last verified
- May 2016
- First submitted
- 3 Aug 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02520037
- Acronym / sponsor ID
- University of Aarhus
- Conditions
- Fluid Responsiveness
- Keywords
- Fluid responsiveness, Volume responsiveness, Hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 11 Aug 2015 (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.
Fluids are generally administered to patients in order to improve circulation. However, fluids do not always improve circulation and fluids have side effects. Unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. it is difficult to predict fluid responsiveness The overall aim of this observational study is to investigate if analysis of spontaneously occuring extra systoles can give the answer: The second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has experienced the compensatory pause, i.e. this beat is associated with increased filling time and in turn associated with increased filling. As such, the post ectopic beat shows how the heart responds to increased filling. Therefore, the hypothesis of this study is that the hemodynamic response to the increased filling at the post ectopic beat (compared with sinus beats) can predict fluid responsiveness
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to a University Hospital intensive care unit
Key inclusion criteria (3 listed)
- Patients scheduled for a 500 ml volume expansion
- Patients without atrial fibrillation
- Patients equipped with ECG, arterial pressure and non-invasive cardiac output monitoring
Key exclusion criteria (5 listed)
- Changes in anesthetic, vasoactive or inotropic drugs during the study period (30 minutes before fluid infusion initiation to end of fluid infusion).
- Changes in positive end-expiratory pressure the study period
- Changes in bed positioning the study period
- Infusion time with crystalloids exceeding 30 minutes
- Infusion time with colloids exceeding 75 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in stroke volume (SV) following fluid administration. A positive fluid response is defined as a 15% or more increase in SV
Time frame: Change in SV from immediately before fluid infusion (t=0 min) to immediately after fluid administration (t < 30 min for crystalloid infusions; t < 75 min for colloid infusions)
A positive fluid response is defined as a 15% or more increase in SV. From the arterial pressure curve, post ectopic changes (comparing with 10 preceding sinus beats) in systolic blood pressure and pre-ejection period will be derived and used to predict the fluid response. Time frame used is the 30 minutes prior to the volume expansion (from t = -30 min to t = 0 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Responsiveness, run by University of Aarhus at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 10 Feb 2017. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in stroke volume (SV) following fluid administration. A positive fluid response is defined as a 15% or more increase in SV (time frame: Change in SV from immediately before fluid infusion (t=0 min) to immediately after fluid administration (t < 30 min for crystalloid infusions; t < 75 min for colloid infusions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.