Fluid ResponsivenessNCT05131516
Peripheral Venous Pressure Variation and Fluid Responsiveness
An observational study of Fluid Responsiveness, run by Erasme University Hospital at 1 site in France.
Trial summary
The decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- Alveolar recrutment maneuver
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2022to 10 Mar 2022
- 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
- Adult, Older adult
Study population: Patients scheduled for a high-risk abdominal surgery ( liver resection and pancreatectomy)
Who may be able to join
- Adult patients
- Patients scheduled for a high-risk abdominal surgery
- Patients equipped with an arterial line connected to an cardiac output hemodynamic monitoring device ( Flotrac, EV1000, Edwards Lifesciences, Irvine, USA)
- Patients in whom a recrutment maneuver is planned as per standard of care
Who cannot join
- Arythmia ( atrial fibrillation)
- Right ventricular dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ability of Peripheral Venous Pressure Variation to Predict Fluid Responsiveness During an Alveolar Recruitment Maneuver in Patients Undergoing Non Cardiac Surgery
The decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid bolus with a significant increase in their cardiac output or stroke volume. Depending on the response to fluids, patients are either responders or non-responders.
Today, we have many techniques to predict fluid responsiveness. However, almost all require the use of an advanced hemodynamic monitoring device.
Read the detailed description
Predicting fluid responsiveness is important in the operating room in order to avoid unnecessary fluid administration. Over the last 15 years, a number of dynamic tests have been developed which are based on the principle of inducing short-term changes in cardiac preload, using heart-lung interactions, the passive leg raise or by the infusion of small volumes of fluid, and to observe the resulting effect on cardiac output or stroke volume. Pulse pressure and stroke volume variations were first developed, but they are reliable only under strict conditions. The variations in vena caval diameters share many limitations of pulse pressure variations. The passive leg-raising test is now supported by solid evidence and is more frequently used but not practical in the operating room. More recently, the end-expiratory occlusion test has also been described, which is easily performed in ventilated patients. Unlike the traditional fluid challenge, these dynamic tests do not lead to fluid overload. The dynamic tests require the insertion of an arterial catheter linked to an advanced cardiac output monitoring device which is costly and not applicable in lower risk patients without an arterial line.
In the operating room, it is recommended to use alveolar recruitment maneuvers, consisting in the transient administration of higher pressure levels, allowing to re-ventilate certain pulmonary territories by re-expanding alveoli that would have collapsed under mechanical ventilation. In daily practice, it is generally accepted that a patient presenting a significant fall in stroke volume or mean arterial pressure during an alveolar recruitment maneuver is preload dependent, but the scientific evidence in the literature remains insufficient to date. A previous study has also demonstrated the ability to predict fluid responsiveness via analysis of central venous pressure during a recruitment maneuver. By extrapolation, we would like to evaluate the capacity of peripheral venous pressure to predict this fluid responsiveness.
- Conditions
- Fluid Responsiveness
- Being tested
- Alveolar recrutment maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recrutment maneuverDiagnostic test
alveolar recruitment maneuver (30 mmHg for 30 seconds)
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the peripheral venous pressure to predict fluid responsiveness
we will induce, before skin incision, an alveolar recrutment maneuver (standard of care) and observe variations of peripheral venous pressure, then, it will be followed by a volume expansion of 4ml/kg over 5 minutes
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start10 Jan 2022
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris-Saclay-Assistance publique des hôpitaux de Paris
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- ALEXANDRE JOOSTEN, MD PhD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131516
- Sponsor's protocol ID
- IRBN902021/CHUSTE
- Status last verified
- Mar 2022
- First submitted
- 16 Nov 2021
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Peripheral Venous Pressure Variation to Predict Fluid Responsiveness During an Alveolar Recruitment Maneuver in Patients Undergoing Non Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05131516
- Acronym / sponsor ID
- IRBN902021/CHUSTE
- Conditions
- Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Université Paris-Saclay-Assistance publique des hôpitaux de Paris
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 23 Nov 2021 (actual)
- 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 decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid bolus with a significant increase in their cardiac output or stroke volume. Depending on the response to fluids, patients are either responders or non-responders.
Today, we have many techniques to predict fluid responsiveness. However, almost all require the use of an advanced hemodynamic monitoring device.
Detailed description
Predicting fluid responsiveness is important in the operating room in order to avoid unnecessary fluid administration. Over the last 15 years, a number of dynamic tests have been developed which are based on the principle of inducing short-term changes in cardiac preload, using heart-lung interactions, the passive leg raise or by the infusion of small volumes of fluid, and to observe the resulting effect on cardiac output or stroke volume. Pulse pressure and stroke volume variations were first developed, but they are reliable only under strict conditions. The variations in vena caval diameters share many limitations of pulse pressure variations. The passive leg-raising test is now supported by solid evidence and is more frequently used but not practical in the operating room. More recently, the end-expiratory occlusion test has also been described, which is easily performed in ventilated patients. Unlike the traditional fluid challenge, these dynamic tests do not lead to fluid overload. The dynamic tests require the insertion of an arterial catheter linked to an advanced cardiac output monitoring device which is costly and not applicable in lower risk patients without an arterial line.
In the operating room, it is recommended to use alveolar recruitment maneuvers, consisting in the transient administration of higher pressure levels, allowing to re-ventilate certain pulmonary territories by re-expanding alveoli that would have collapsed under mechanical ventilation. In daily practice, it is generally accepted that a patient presenting a significant fall in stroke volume or mean arterial pressure during an alveolar recruitment maneuver is preload dependent, but the scientific evidence in the literature remains insufficient to date. A previous study has also demonstrated the ability to predict fluid responsiveness via analysis of central venous pressure during a recruitment maneuver. By extrapolation, we would like to evaluate the capacity of peripheral venous pressure to predict this fluid responsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a high-risk abdominal surgery ( liver resection and pancreatectomy)
Key inclusion criteria (4 listed)
- Adult patients
- Patients scheduled for a high-risk abdominal surgery
- Patients equipped with an arterial line connected to an cardiac output hemodynamic monitoring device ( Flotrac, EV1000, Edwards Lifesciences, Irvine, USA)
- Patients in whom a recrutment maneuver is planned as per standard of care
Key exclusion criteria (2 listed)
- Arythmia ( atrial fibrillation)
- Right ventricular dysfunction
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 |
|---|---|---|
| Alveolar recrutment maneuveralveolar recruitment maneuver (30 mmHg for 30 seconds) | Diagnostic test | – |
Primary outcome
Ability of the peripheral venous pressure to predict fluid responsiveness
Time frame: during surgery
we will induce, before skin incision, an alveolar recrutment maneuver (standard of care) and observe variations of peripheral venous pressure, then, it will be followed by a volume expansion of 4ml/kg over 5 minutes
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 28 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Fluid Responsiveness
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
RecruitingObservational study
Dynamic SvO2 in Predicting Fluid Responsiveness in Septic Shock
Sepsis and Septic Shock
Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
Not yet recruitingObservational study
Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Hemorrhagic Shock, Trauma
Not yet recruitingObservational study
This Study Compares Two Noninvasive Dynamic Tools: Lung Ultrasound and Transthoracic Echocardiography Using LVOT VTI. It Aims to Measure the Sensitivity and Specificity of LUS in Guiding Fluid Resuscitation and Early Detection of Fluid Responsiveness and to Prevent Volume Overload
Septic Shock, Fluid Reponsiveness
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.
ALEXANDRE JOOSTEN, MD PhD principal investigator
ERASME
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 Erasme University Hospital at 1 site in France.
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 4 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 28 Mar 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 France. 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?
Ability of the peripheral venous pressure to predict fluid responsiveness (time frame: during surgery). 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 28 Mar 2022.