HemodynamicsPOPNCT02571465
Assessment of Fluid Responsiveness in Patients After Cardiac Surgery
An observational study of Hemodynamics and Patient Monitoring, run by Triemli Hospital at 1 site in Switzerland.
Trial summary
To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodynamics, Patient Monitoring
- What is being tested?
- Passive leg raising test and fluid challenge
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Dec 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective off-pump CABG
Who may be able to join
- preserved left ventricular function
- regular heart rhythm
Who cannot join
- emergency procedures
- intra- and extra-cardial shunts
- aortic and tricuspid valve insufficiencies
- peripheral arterial occlusive disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Fluid Responsiveness in Patients After Cardiac Surgery Comparison of Different Functional Hemodynamic Parameters and Tests
To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.
Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the transition from controlled to spontaneous breathing in cardiac surgery patients
Read the detailed description
In patients after elective off-pump CABG are enrolled hemodynamic measurements are performed in the postoperative period upon arrival in the ICU using a PiCCO2 system (Pulsion Medical Systems, Munich, Germany).
Controlled fluid challenges (500 ml) are done at 3 time-points:
- during controlled mechanical ventilation B) during pressure support ventilation with spontaneous breathing and C) after extubation.
Stroke volume (SV), SVV and PPV as well as standard hemodynamic parameters (MAP = mean arterial pressure, HR = heart rate) are assessed.
A PLR is performed before fluid administration at all 3 time points. A positive response is defined as an increase in SV>15 %.
Prediction of fluid responsiveness will be tested by AUC (area under the receiver operating characteristic - ROC - curve).
- Conditions
- Hemodynamics, Patient Monitoring
- Being tested
- Passive leg raising test and fluid challenge
- Keywords
- functional hemodynamic parameter, passive leg raising, stroke volume variation, pulse pressure variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg raising test and fluid challengeOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume increase > 15%
Stroke volume increase defines fluid responsiveness
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionDec 2015
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 HemodynamicsStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph K Hofer, Triemli Hospital
- Investigators
- Christoph K Hofer, MD DEAA, Principal investigator, Triemli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571465
- Sponsor's protocol ID
- IFA10-3
- Acronym
- POP
- Status last verified
- Nov 2016
- First submitted
- 7 Oct 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
PubMed 19602972Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
PubMed 16540963Ganter MT, Geisen M, Hartnack S, Dzemali O, Hofer CK. Prediction of fluid responsiveness in mechanically ventilated cardiac surgical patients: the performance of seven different functional hemodynamic parameters. BMC Anesthesiol. 2018 May 22;18(1):55. doi: 10.1186/s12871-018-0520-x.
PubMed 29788919
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fluid Responsiveness in Patients After Cardiac Surgery Comparison of Different Functional Hemodynamic Parameters and Tests
- ClinicalTrials.gov ID
- NCT02571465
- Acronym / sponsor ID
- POP / IFA10-3
- Conditions
- Hemodynamics, Patient Monitoring
- Keywords
- functional hemodynamic parameter, passive leg raising, stroke volume variation, pulse pressure variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Oct 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.
To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.
Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the transition from controlled to spontaneous breathing in cardiac surgery patients
Detailed description
In patients after elective off-pump CABG are enrolled hemodynamic measurements are performed in the postoperative period upon arrival in the ICU using a PiCCO2 system (Pulsion Medical Systems, Munich, Germany).
Controlled fluid challenges (500 ml) are done at 3 time-points:
- during controlled mechanical ventilation B) during pressure support ventilation with spontaneous breathing and C) after extubation.
Stroke volume (SV), SVV and PPV as well as standard hemodynamic parameters (MAP = mean arterial pressure, HR = heart rate) are assessed.
A PLR is performed before fluid administration at all 3 time points. A positive response is defined as an increase in SV>15 %.
Prediction of fluid responsiveness will be tested by AUC (area under the receiver operating characteristic - ROC - curve).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective off-pump CABG
Key inclusion criteria (2 listed)
- preserved left ventricular function
- regular heart rhythm
Key exclusion criteria (4 listed)
- emergency procedures
- intra- and extra-cardial shunts
- aortic and tricuspid valve insufficiencies
- peripheral arterial occlusive disease
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 |
|---|---|---|
| Passive leg raising test and fluid challenge | Other | – |
Primary outcome
Stroke volume increase > 15%
Time frame: 20 min
Stroke volume increase defines fluid responsiveness
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 15 Nov 2016.
- Background: PubMed 19602972Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
- Background: PubMed 16540963Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
- Derived from this study: PubMed 29788919Ganter MT, Geisen M, Hartnack S, Dzemali O, Hofer CK. Prediction of fluid responsiveness in mechanically ventilated cardiac surgical patients: the performance of seven different functional hemodynamic parameters. BMC Anesthesiol. 2018 May 22;18(1):55. doi: 10.1186/s12871-018-0520-x.
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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.
Christoph K Hofer, MD DEAA principal investigator
Triemli City Hospital
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 Hemodynamics and Patient Monitoring, run by Triemli Hospital at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 15 Nov 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 Switzerland. 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?
Stroke volume increase > 15% (time frame: 20 min). 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 NCT02571465, 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 15 Nov 2016.