Hemodynamic Optimization During Major Urological Surgery

Study Overview
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Brief Summary
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In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).

Detailed Description
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During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.

Official Title
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Correlation Between IN-TArget Time for Mean Arterial Pressure and Stroke Volume During Major Urological Surgery and Tissue Perfusion: the INTAT Observational Study

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Device: Ev1000 Clinical Platform from Edwards Lifesciences


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for major urological surgery ASA 1-2-3 Exclusion Criteria: pregnancy obesity with a BMI > 35 controindications to central venous catheter positioning end-stage renal disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FloTrac patients<br>patients belong to this group will be managed with a stroke volume target hemodynamic protocol | Device: Ev1000 Clinical Platform from Edwards Lifesciences<br>* The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery | The primary outcome will explore the hypothesis that patient with higher adherence of MAP levels above 65 mmHg will have a lower pCO2 gap at the end of surgery | an average of 8 hours | 
| Correlation between the time-in target of SV and the pCO2 gap at the end of surgery | The co-primary outcome will explore the hypothesis that patient with higher adherence of SV within the maximum value with a 10% tolerance, will have a lower pCO2 gap at the end of surgery | an average of 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative overall complications | investigators will assess the impact of the intraoperative hemodynamic optimization on the rate of postoperative complications | up to 30 days | 
| duration of hospitalization | investigators will prospectively evaluate the association between an intraoperative goal-directed fluid therapy with the long of stay | an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke volume, goal directed therapy, major urological surgery, mean arterial pressure