Cardiac Output, HighNCT02778620
Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Aortic Valve Replacement
An observational study of Cardiac Output, High, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, High
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2013to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post-aortic valve replacement patients
Who may be able to join
- Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter.
- Patients will be subsequently connected to the hemodynamic monitoring device Navigator™.
- In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.
Who cannot join
- Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study.
- Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Aortic Valve Replacement
The purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.
Read the detailed description
The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant. However, in determining the fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. Passive leg raising (PLR) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.
- Conditions
- Cardiac Output, High
- Keywords
- Volume responsiveness mean systemic filling pressure
- Medical subject headings
- Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aortic Valve Replacement | Post Anaesthetic Care Unit (PACU) patients treated with aortic valve replacement (AVR) are highly eligible for this study.These are patients with an indication for fast track treatment (PACU) post-cardiac surgery with a good left ventricular ejection fraction without significant co-morbidity. The final decision for PACU-classification is taken by the responsible anaesthesiologist and intensivist in close collaboration with the cardiothoracic surgeon performing the operation, as well as the cardiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systemic filling pressure (Pms)
An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient
Measured: 1 hour
Secondary outcomes (1)
Heart performance (eH)
Quotient of driving pressure of venous return in mmHg
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, HighStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, L.P.B. Meijs, Catharina Ziekenhuis Eindhoven
- Investigators
- Jan Bakker, MD, PhD, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778620
- Sponsor's protocol ID
- M12-1270
- Status last verified
- Dec 2019
- First submitted
- 18 May 2016
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No, data remain anonymized within hospital and property of PI.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT02778620
- Acronym / sponsor ID
- M12-1270
- Conditions
- Cardiac Output, High
- Keywords
- Volume responsiveness mean systemic filling pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 May 2016 (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 determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.
Detailed description
The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant. However, in determining the fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. Passive leg raising (PLR) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic Valve Replacement | – | –Post Anaesthetic Care Unit (PACU) patients treated with aortic valve replacement (AVR) are highly eligible for this study.These are patients with an indication for fast track treatment (PACU) post-cardiac surgery with a good left ventricular ejection fraction without significant co-morbidity. The final decision for PACU-classification is taken by the responsible anaesthesiologist and intensivist in close collaboration with the cardiothoracic surgeon performing the operation, as well as the cardiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-aortic valve replacement patients
Key inclusion criteria (3 listed)
- Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter.
- Patients will be subsequently connected to the hemodynamic monitoring device Navigator™.
- In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.
Key exclusion criteria (2 listed)
- Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study.
- Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.
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
Mean systemic filling pressure (Pms)
Time frame: 1 hour
An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient
1 secondary outcome
Heart performance (eH)
Time frame: 1 hour
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 18 Dec 2019.
- Individual participant dataSharing planned: No. No, data remain anonymized within hospital and property of PI.
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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.
Jan Bakker, MD, PhD study chair
Erasmus Medical Center
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 Cardiac Output, High, run by Catharina Ziekenhuis Eindhoven 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 2 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 18 Dec 2019. 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?
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?
Mean systemic filling pressure (Pms) (time frame: 1 hour). 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 18 Dec 2019; AzTrials last refreshed its copy on 1 Nov 2026.