Hemodynamic Instability
Conditions
Keywords
CO2 gap, oxygen consumption, Stroke volume optimization
Brief summary
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.
Interventions
OTHEROxygen consumption optimization
hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio
Sponsors
Flavia Torrini
Alessandra Bisanti
Eleonora Filipponi
Domenica Luca Grieco
Massimo Antonelli
Liliana Sollazzi
Valter Perilli
Andrea Russo
Pierpaolo Ciocchetti
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Absolute contraindication to CVC placement * pregnant women * hepatic surgery * laparoscopic surgery * Major vascular surgery * Dialysis treatment and kidney transplant surgery * Severe heart failure (EF ≤ 35%) * Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative fluid balance | surgery | Perioperative fluid balance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival at 28 days | 28 days after surgery | Patients who survived at 28 days |
| Survival at hospital discharge | 1 day (Hospital discharge) | Patient who survived at hospital discharge |
| Post-operative complication | 1 day (Hospital discharge) | Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI |
Countries
Italy
Contacts
Primary ContactAntonio M Dell'Anna, MD
Outcome results
None listed