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| Name | Class |
|---|---|
| Flavia Torrini | UNKNOWN |
| Alessandra Bisanti | UNKNOWN |
| Eleonora Filipponi | UNKNOWN |
| Domenica Luca Grieco |
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This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | No Intervention | In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization | |
| NICE group | Active Comparator | In this arm patients will be treated according to stroke volume optimization described in NICE program |
|
| Oxygen consumption group | Experimental | In this arm patients will receive hemodynamic optimization based on their oxygen consumption need |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen consumption optimization | Other | hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative fluid balance | Perioperative fluid balance | surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 28 days | Patients who survived at 28 days | 28 days after surgery |
| Survival at hospital discharge | Patient who survived at hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio M Dell'Anna, MD | Contact | +390630154490 | anthosdel@yahoo.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio M Dell'Anna, MD | Fondazione Policlinico Universitario A. Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico A. Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| UNKNOWN |
| Massimo Antonelli | UNKNOWN |
| Liliana Sollazzi | UNKNOWN |
| Valter Perilli | UNKNOWN |
| Andrea Russo | UNKNOWN |
| Pierpaolo Ciocchetti | UNKNOWN |
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| 1 day (Hospital discharge) |
| Post-operative complication | Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI | 1 day (Hospital discharge) |