Fluid Responsiveness PredictabilityFC_EEOTNCT06627907
Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room.
An observational study of Fluid Responsiveness Predictability, run by Humanitas Clinical and Research Center.
Trial summary
Personalzing intraoperative anesthetic fluid management may help in preventing fluid accumulation and related complications. Fluids are gine as boluses in operating room (the so-called FC). The response to the FC is due to several physiological conditions related to the "preload dependency" (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness Predictability
- What is being tested?
- fluid challenge and end-expiratory occlusion test
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Sep 2026
- How long will I take part?
- 1 Day
- 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: Elective abdominal or neuro surgery
Who may be able to join
- Adult patients aged ≥ 18 years
- Scheduled for elective supine abdominal laparotomic or neuro surgery, requiring invasive arterial monitoring and continuous hemodynamic monitoring
- All the patients must be able to sign an informed consent at the admission
Who cannot join
- Any recurrent cardiac arrhythmias
- Reduced left (ejection fraction <30%) or right (systolic peak velocity of tricuspid annular motion <0.17 m/s) ventricular systolic function
- Urgent / Emergent surgery
- Liver surgery
- Laparoscopic surgery
Trial locations and contacts
No sites are listed yet.
About this study
Personalzing intraoperative anesthetic fluid management may help in preventing fluid accumulation and related complications.
Fluids are gine as boluses in operating room (the so-called FC). The response to the FC is due to several physiological conditions related to the "preload dependency" (i.e. the intrinsic ability of the heart of increasing the stroke volume - SV - in response to fluid administration).
Read more
The minimal volume required to appropriately "challenge" the cardiovascular system is 4 ml/kg of fluid, but higher volumes (up to 6 ml/kg may be needed).
Predicting the response to FC administration may be possible by applying a physiological test (called functional hemodynamic test), such as the end-expiratory occlusion test, consisting in interrupping the mechanical ventilation and hence promoting venous return and consequente SV changes. The percentage of SV increase associated to EEOT may predict fluid responsiveness to the FC (patients responders will increase SV to a bigger extent, as compared to non-responders)
Read the detailed description
A two-step statistical approach will be used to define the best model to predict the fluid responsiveness.
- A univariable logistic regression model to test the association of the considered hemodynamic variables provided by the hemodynamic monitoring with the primary outcome (fluid responsiveness at 10th minute). Then a multivariable analysis incorporating the variable in univariable analysis with a p < 0.2, after testing the colinearity and interactions. Significance threshold for multivariable analysis will be set to 0.05
- A Hosmer and Lemeshow test was calculated to evaluate goodness of fit for the logistic regression model, the Informative criterion metrics, such as Akaike Infromation Criterion, AIC) and the receiver operating characteristic (ROC) curve [standard error, (SE)] analysis evaluated the performance of predictive items for FC response (i.e.Y = dependent variable =SVI increasedby ≥ 10%) 10 minutes (Y10) after FC infusion. The absence of a significant increase in the likelihood value afteromission of each of the remaining variables was checked.
To define the best model to predict the amount of fluid in responder group a machine-learning approach will be considered where Y = dependent variable = total amount of crystalloids to obtained SVI ≥ 10% after FC infusion, X = matrix of parameters. The final model decision will be made among following commonly used regression algorithms: linear reagression, Lasso Regression or Ridge Regression. The model performance assessment will be made using metrics like Mean Squared Error (MSE) or R-squared. K-fold cross-validation technique will be applied to get a more robust estimate of the model's performance.
The hemodynamic values of responders and non-responders at each step of the protocol are analyzed with a one -way analysis of variance for repeated measurements (ANOVA) and Geisser -Greenhouse (G-G) correction as ajustement for lack of sphericity if needed. Post-hoc pairwise multiple comparisons analysis are performed using Tukey's test to control familywise error.
To understand whether hemodynamic changes after EEOT could help in the prediction of minimal dose of FC the study will enroll 2-year evaluable patients, and the final numer will be foreseen in about 300, with aroud 500 fluid challenge.
The sample size will allow us to perform three step:
- an initial step of 50 patients to understand which variables of hemodynamic changes after EEOT will affect the minimal dose of FC. In this initial part a variable will be considered interesting if the relative p value will be under 0.1 5. A second step including 200 patients' data to create the model, considering also variables interactions 6. A finel step of 50 patients to validate the model
- Conditions
- Fluid Responsiveness Predictability
- Being tested
- fluid challenge, end-expiratory occlusion test
- Keywords
- Fluid challenge, End-expiratory occlusion test, FLuid responsiveness, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid challengeOther
The study protocol is started during a period of intraoperative hemodynamic stability, as previously defined (i.e. change in mean arterial pressure of less than 10% during 5 minutes [32, 33]). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline 2) (T1) after one minute the EEOT is then performed by stopping the mechanical ventilation for 30 seconds (T2 - end of the EEOT test); 3) (T3) a FC of overall 6 mL/Kg of crystalloid solution is infused over 10 minutes (T4 end of the FC). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment.
The protocol is entirely intraoperative and data collections ends after FC administration. No follow-up is needed.
The mentioned timepoints T0 - T1 - T2, corresponding to intrapeortive data recording points are also the endpoints of the study. At each specific timepoint, a marker is added to the M
end-expiratory occlusion testDiagnostic test
The study protocol is started during a period of intraoperative hemodynamic stability, as previously defined (i.e. change in mean arterial pressure of less than 10% during 5 minutes [32, 33]). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline 2) (T1) after one minute the EEOT is then performed by stopping the mechanical ventilation for 30 seconds (T2 - end of the EEOT test); 3) (T3) a FC of overall 6 mL/Kg of crystalloid solution is infused over 10 minutes (T4 end of the FC). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment.
The protocol is entirely intraoperative and data collections ends after FC administration. No follow-up is needed.
The mentioned timepoints T0 - T1 - T2, corresponding to intrapeortive data recording points are also the endpoints of the study. At each specific timepoint, a marker is added to the M
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients receiving a fluid challenge Receives: Other: fluid challenge; Diagnostic Test: end-expiratory occlusion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness
stroke volume index > or equal to 10%
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Responsiveness PredictabilityStudies 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
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627907
- Sponsor's protocol ID
- FC_EEOT
- Acronym
- FC_EEOT
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room.
- ClinicalTrials.gov ID
- NCT06627907
- Acronym / sponsor ID
- FC_EEOT / FC_EEOT
- Conditions
- Fluid Responsiveness Predictability
- Keywords
- Fluid challenge, End-expiratory occlusion test, FLuid responsiveness, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 4 Oct 2024 (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.
Personalzing intraoperative anesthetic fluid management may help in preventing fluid accumulation and related complications.
Fluids are gine as boluses in operating room (the so-called FC). The response to the FC is due to several physiological conditions related to the "preload dependency" (i.e. the intrinsic ability of the heart of increasing the stroke volume - SV - in response to fluid administration).
The minimal volume required to appropriately "challenge" the cardiovascular system is 4 ml/kg of fluid, but higher volumes (up to 6 ml/kg may be needed).
Predicting the response to FC administration may be possible by applying a physiological test (called functional hemodynamic test), such as the end-expiratory occlusion test, consisting in interrupping the mechanical ventilation and hence promoting venous return and consequente SV changes. The percentage of SV increase associated to EEOT may predict fluid responsiveness to the FC (patients responders will increase SV to a bigger extent, as compared to non-responders)
Detailed description
A two-step statistical approach will be used to define the best model to predict the fluid responsiveness.
- A univariable logistic regression model to test the association of the considered hemodynamic variables provided by the hemodynamic monitoring with the primary outcome (fluid responsiveness at 10th minute). Then a multivariable analysis incorporating the variable in univariable analysis with a p < 0.2, after testing the colinearity and interactions. Significance threshold for multivariable analysis will be set to 0.05
- A Hosmer and Lemeshow test was calculated to evaluate goodness of fit for the logistic regression model, the Informative criterion metrics, such as Akaike Infromation Criterion, AIC) and the receiver operating characteristic (ROC) curve [standard error, (SE)] analysis evaluated the performance of predictive items for FC response (i.e.Y = dependent variable =SVI increasedby ≥ 10%) 10 minutes (Y10) after FC infusion. The absence of a significant increase in the likelihood value afteromission of each of the remaining variables was checked.
To define the best model to predict the amount of fluid in responder group a machine-learning approach will be considered where Y = dependent variable = total amount of crystalloids to obtained SVI ≥ 10% after FC infusion, X = matrix of parameters. The final model decision will be made among following commonly used regression algorithms: linear reagression, Lasso Regression or Ridge Regression. The model performance assessment will be made using metrics like Mean Squared Error (MSE) or R-squared. K-fold cross-validation technique will be applied to get a more robust estimate of the model's performance.
The hemodynamic values of responders and non-responders at each step of the protocol are analyzed with a one -way analysis of variance for repeated measurements (ANOVA) and Geisser -Greenhouse (G-G) correction as ajustement for lack of sphericity if needed. Post-hoc pairwise multiple comparisons analysis are performed using Tukey's test to control familywise error.
To understand whether hemodynamic changes after EEOT could help in the prediction of minimal dose of FC the study will enroll 2-year evaluable patients, and the final numer will be foreseen in about 300, with aroud 500 fluid challenge.
The sample size will allow us to perform three step:
- an initial step of 50 patients to understand which variables of hemodynamic changes after EEOT will affect the minimal dose of FC. In this initial part a variable will be considered interesting if the relative p value will be under 0.1 5. A second step including 200 patients' data to create the model, considering also variables interactions 6. A finel step of 50 patients to validate the model
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: fluid challenge, Diagnostic Test: end-expiratory occlusion testPatients receiving a fluid challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective abdominal or neuro surgery
Key inclusion criteria (3 listed)
- Adult patients aged ≥ 18 years
- Scheduled for elective supine abdominal laparotomic or neuro surgery, requiring invasive arterial monitoring and continuous hemodynamic monitoring
- All the patients must be able to sign an informed consent at the admission
Key exclusion criteria (5 listed)
- Any recurrent cardiac arrhythmias
- Reduced left (ejection fraction <30%) or right (systolic peak velocity of tricuspid annular motion <0.17 m/s) ventricular systolic function
- Urgent / Emergent surgery
- Liver surgery
- Laparoscopic surgery
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 |
|---|---|---|
| fluid challengeThe study protocol is started during a period of intraoperative hemodynamic stability, as previously defined (i.e. change in mean arterial pressure of less than 10% during 5 minutes [32, 33]). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline 2) (T1) after one minute the EEOT is then performed by stopping the mechanical ventilation for 30 seconds (T2 - end of the EEOT test); 3) (T3) a FC of overall 6 mL/Kg of crystalloid solution is infused over 10 minutes (T4 end of the FC). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment. The protocol is entirely intraoperative and data collections ends after FC administration. No follow-up is needed. The mentioned timepoints T0 - T1 - T2, corresponding to intrapeortive data recording points are also the endpoints of the study. At each specific timepoint, a marker is added to the M | Other | Group 1 |
| end-expiratory occlusion testThe study protocol is started during a period of intraoperative hemodynamic stability, as previously defined (i.e. change in mean arterial pressure of less than 10% during 5 minutes [32, 33]). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline 2) (T1) after one minute the EEOT is then performed by stopping the mechanical ventilation for 30 seconds (T2 - end of the EEOT test); 3) (T3) a FC of overall 6 mL/Kg of crystalloid solution is infused over 10 minutes (T4 end of the FC). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment. The protocol is entirely intraoperative and data collections ends after FC administration. No follow-up is needed. The mentioned timepoints T0 - T1 - T2, corresponding to intrapeortive data recording points are also the endpoints of the study. At each specific timepoint, a marker is added to the M | Diagnostic test | Group 1 |
Primary outcome
fluid responsiveness
Time frame: 10 minutes
stroke volume index > or equal to 10%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Fluid Responsiveness Predictability in Sepsis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Responsiveness Predictability, run by Humanitas Clinical and Research Center.
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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Messina, PhD (+390282241, antonio.messina@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid responsiveness (time frame: 10 minutes). 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 8 Oct 2024.