About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged > 18 years
acquisition of written informed consent
Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours
Disqualifiers
Absolute contraindication to CVC placement
pregnant women
hepatic surgery
laparoscopic surgery
Trial design
Parallel
Treatments tested in this trial
Oxygen consumption optimization
Other interventionhemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio
Treatment groups
Trial outcomes
Primary outcomes
Perioperative fluid balance
Perioperative fluid balance
Secondary outcomes
Survival at 28 days
Patients who survived at 28 days
Survival at hospital discharge
Patient who survived at hospital discharge
Post-operative complication
Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI
Sponsors and contacts
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Flavia Torrini
Collaborator
Alessandra Bisanti
Collaborator
Eleonora Filipponi
Collaborator
Domenica Luca Grieco
Collaborator
Massimo Antonelli
Collaborator
Liliana Sollazzi
Collaborator
Valter Perilli
Collaborator
Andrea Russo
Collaborator
Pierpaolo Ciocchetti
Collaborator