Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Oxygen consumption optimization

    Other intervention

    hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio

Treatment groups

76 Participants
are divided into 3 treatment groups
Group A: StandardNo intervention 0 interventions
Group B: NICE groupActive comparator 1 intervention
Group C: Oxygen consumption groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Perioperative fluid balance

Perioperative fluid balance

Time frame
surgery

Secondary outcomes

1

Survival at 28 days

Patients who survived at 28 days

Time frame
28 days after surgery
2

Survival at hospital discharge

Patient who survived at hospital discharge

Time frame
1 day (Hospital discharge)
3

Post-operative complication

Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI

Time frame
1 day (Hospital discharge)

Other outcomes

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