An observational study in Fluid Responsiveness Predictability, sponsored by Humanitas Clinical and Research Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Humanitas Clinical and Research Center · Observational
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)
A two-step statistical approach will be used to define the best model to predict the fluid responsiveness.
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:
Humanitas Clinical and Research Center is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
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Elective abdominal or neuro surgery
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving a fluid challenge
Other: fluid challenge · Diagnostic Test: end-expiratory occlusion 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
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
fluid responsiveness
stroke volume index \> or equal to 10%
Time frame: 10 minutes
No study locations are listed for this record.
Start is estimated for Nov 2024; primary completion for Jun 2026, 19 months later.
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Humanitas Clinical and Research Center